Active Studies, No Longer Enrolling

My Transgender Brain Study (MyT "Mighty" Brain) - Colorado

Principal Investigator: Aileen Norton
Protocol #18-1740, No Longer Enrolling: 8/24/2021
Locations: Anschutz Health and Wellness; Outpatient CTRC; UCD Anschutz Health & Wellness Center; University of Colorado Hospital;

Relationship of hair cortisol to diurnal salivary cortisol and psychological distress measures

The purpose of this research is to demonstrate a relationship between cortisol measured in hair, cortisol measured in saliva, and the results of self-reported psychological measures (questionnaires).

Principal Investigator: Julia Byers
Protocol #20-0025, No Longer Enrolling: 1/21/2021
Location: Department Specific Free Standing Clinic;

The role of biological sex in perceived stress and negative affect in the context of 2 systemic societal stressors

This study is completed online at your convenience. Participants will complete online surveys (the study takes about 25 minutes to complete).

Principal Investigator: Andrew Novick
Protocol #20-1583, No Longer Enrolling: 10/14/2020
Location: Department Specific Free Standing Clinic;

The SUN Clinical Trial: Safety Utilizing NUsurface Meniscus Implant. A multi-center, single-arm, prospective, open label, non-randomized, observational clinical study

Protocol #15-1356, No Longer Enrolling: 10/1/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02483988

A Clinical Study to Assess the Safety and Effectiveness of the Premia Spine TOPS System

Principal Investigator: Claire Cofer
Protocol #17-0054, No Longer Enrolling: 3/11/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03012776

Study of bone growth in the Sacroiliac Joint after minimally invasive surgery with titanium implants

Principal Investigator: Claire Cofer
Protocol #17-0371, No Longer Enrolling: 1/8/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03122899

A Multi-Center, Open-Label, Prospective Study of CervicalStim device as Adjunctive Care following Cervical Fusion

Principal Investigator: Claire Cofer
Protocol #17-1013, No Longer Enrolling: 8/25/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03177473

SMART: A prospective, multi-center registry assessing the embolization of neurovascular lesions using the Penumbra SMART COIL? System

This is a prospective, multi-center registry of patients treated in accordance with the cleared indications for the Smart, Penumbra Coil 400, and the Penumbra Occlusion Device. Data for each patient are collected in accordance with the standard of care at each participating hospital through one-year follow-up.

Principal Investigator: David Case
Protocol #17-2122, No Longer Enrolling: 7/17/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02729740

A Prospective Multicenter Open-label Randomized Controlled Trial of Agili-C vs. Surgical Standard of Care (SSOC) for the Treatment of Joint Surface Lesions of the Knee

The Agili-C™ scaffold is indicated for the treatment of an ICRS grade III or above knee-joint surface lesion(s), with a total treatable area of 1-7cm2 and without severe osteoarthritis (Kellgren-Lawrence grade 0-3)

Principal Investigator: Jeffery Wilson
Protocol #18-2105, No Longer Enrolling: 1/3/2020
Locations: Boulder Sports Clinic; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03299959

A Prospective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children with Osteogenesis Imperfecta V: 24 March 2016

Principal Investigator: Marcie Terry
Protocol #18-0073, No Longer Enrolling: 1/15/2020
Location: Childrens Hospital Colorado;

A Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 Delivered By Single or Multi-Dose Intravitreal Injections(s) to Subjects With Acute Nonarteritic Anterior Ischemic Optin Neuropathy (NAION)

1. To assess the safety and tolerability of QPI-1007 intravitreal (IVT) injections in subjects with recent-onset NAION 2. To determine the effect on visual function of QPI-1007 IVT injections in subjects with recent-onset NAION

Protocol #15-1194, No Longer Enrolling: 11/20/2019
Location: University of Colorado Hospital;

A Multicenter, Open-Label, Extension Study to Evaluate the Long-term Safety and Efficacy of Patisiran in Patients with Familial Amyloidotic Polyneuropathy Who Have Completed a Prior Clinical Study with Patisiran

To assess the safety and efficacy of long-term dosing with patisiran in transthyretin-mediated amyloidosis (ATTR) patients with familial amyloidotic polyneuropathy (FAP).

Principal Investigator: Dianna Quan
Protocol #15-1259, No Longer Enrolling: 4/25/2020
Location: University of Colorado Hospital;

A Phase 3 Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and the Safety of Gastric Retentive, Controlled Release Accordion Pill Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson's Disease Patients

To assess the safety, tolerability and efficacy of Accordion Pill carbidopa/levodopa (AP-CD/LD) compared to Immediate Release carbidopa/levodopa (IR CD/LD) in fluctuating PD patients

Protocol #15-2350, No Longer Enrolling: 10/1/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02605434

An Open-Label, Phase 3 Study Examining the Long-Term Safety Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients with Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes)

To evaluate the safety and tolerability of APL-130277 in patients with Parkinson's disease (PD) over a 24 week period

Principal Investigator: Donna Wilber
Protocol #16-0684, No Longer Enrolling: 1/29/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02542696

A Double-Masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders

To compare the efficacy of MEDI-551 versus placebo in reducing the risk of an NMO/NMOSD attack in subjects with NMO/NMOSD.

Principal Investigator: Donna Wilber
Protocol #14-0926, No Longer Enrolling: 4/25/2020
Location: University of Colorado Hospital;

RNS System Post-Approval Study in Epilepsy

To calculate annual SAE rate over time in patients treated with RNS System

Protocol #15-1458, No Longer Enrolling: 11/2/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02403843

A randomized, double-blind, placebo-controlled trial of urate-elevating inosine treatment to slow clinical decline in early Parkinson!?s disease

To determine whether oral inosine dosed to moderately elevate serum urate (from !U5.7 mg/dL to 7.1-8.0 mg/dL) over 2 years slows clinical decline in early PD.

Protocol #15-2328, No Longer Enrolling: 11/14/2019
Location: University of Colorado Hospital;

Wireless electroencephalography for continuous monitoring in the EEG LTM unit 12Apr2018

1. To evaluate the device?s ability to record wireless EEG from patients in the long-term EEG monitoring unit 2. To compare wireless EEG in these recordings to standard-of-care wired EEG

Principal Investigator: Donna Wilber
Protocol #15-0449, No Longer Enrolling: 8/10/2021
Location: University of Colorado Hospital;

A Phase 3, Open-Label Study of the Safety, Efficacy, and Tolerability of Apomorphine Administered by Continuous Subcutaneous Infusion in Advanced Parkinson's Disease Patients with Unsatisfactory Control on Available Therapy.

To assess the long-term safety of apomorphine continuous infusion in advanced Parkinson?s disease (PD) patients who are unable to achieve adequate motor control despite optimal treatment with noninvasive therapy.

Principal Investigator: Donna Wilber
Protocol #15-1274, No Longer Enrolling: 4/25/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02339064

A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312

To demonstrate the efficacy of BAF312 relative to placebo in delaying the time to 3-month confirmed disability progression in patients with SPMS as measured by EDSS.

Principal Investigator: Donna Wilber
Protocol #13-2286, No Longer Enrolling: 4/15/2020
Location: University of Colorado Hospital;

A Phase III, multicentre, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis

To investigate the efficacy of ocrelizumab compared with placebo in patients with primary progressive multiple sclerosis, as measured by the time to onset of confirmed disability progression over the treatment period, defined as an increase in EDSS that is sustained for at least 12 weeks, based on regularly scheduled visits.

Protocol #11-1327, No Longer Enrolling: 11/12/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT01194570

A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study to Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1A (Rebif ?) in Patients with Relapsing Multiple Sclerosis

To assess whether the efficacy of ocrelizumab 600 mg (given as dual infusions of 300 mg on Days 1 and 15 of the first 24-week treatment cycle and as a single infusion of 600 mg on Day 1 of each 24-week treatment cycle thereafter) intravenously every 24 weeks is superior to Rebif? as measured by the annualized protocol-defined relapse rate by two years (96 weeks) in patients with relapsing multiple sclerosis.

Protocol #11-1850, No Longer Enrolling: 11/12/2019
Location: University of Colorado Hospital;

Effect of MD1003 in progressive multiple sclerosis: a randomized double blind placebo controlled study

To demonstrate the superiority of MD1003, 300 mg/day, over placebo to clinically improve patients with progressive multiple sclerosis (MS).

Principal Investigator: Donna Wilber
Protocol #16-1727, No Longer Enrolling: 4/25/2020
Location: University of Colorado Hospital;

A Multicenter, Double-Blind, Double-Dummy Study to Explore the Long-Term Safety and Efficacy of TEV-48125 for the Prevention of Cluster Headache

Protocol #17-0089, No Longer Enrolling: 11/6/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03107052

Deep Brain Stimulation (DBS) of the Rostral Zona Incerta (rZI) for Parkinson's Disease (PD): Stereotactic Targeting and Clinical Efficacy

Principal Investigator: Drew Kern
Protocol #16-1443, No Longer Enrolling: 6/10/2021
Location: University of Colorado Hospital;

Cognition and Neurodevelopmental Influence (CANDI)

Principal Investigator: Donna Wilber
Protocol #17-0207, No Longer Enrolling: 12/10/2019
Location: University of Colorado Hospital;

10-1311 DoneSave Functional connectivity of the motor network in two major subtypes of Parkinson Disease December 24,2015

Principal Investigator: Brian Berman
Protocol #10-1311, No Longer Enrolling: 7/30/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT01798563

Dystonia Coalition Project 1: Natural History and Biospecimen Repository for Dystonia

Principal Investigator: Brian Berman
Protocol #11-0647, No Longer Enrolling: 5/10/2021
Location: University of Colorado Hospital;

MULTICENTER 1-YEAR OBSERVATIONAL STUDY OF PATIENTS WHO ARE INITIATING BRIVARACETAM

Principal Investigator: Donna Wilber
Protocol #17-0679, No Longer Enrolling: 10/9/2020
Location: University of Colorado Hospital;

Diagnostic and Rating Tools for Blepharospasm

Principal Investigator: Brian Berman
Protocol #16-0017, No Longer Enrolling: 5/10/2021
Location: University of Colorado Hospital;

A Phase III, Multicentre, Randomised, Double Blind, Parallel Group, Placebo Controlled Study to Assess the Efficacy And Safety of One or More Intradetrusor Treatments of 600 or 800 Units of Dysport? For The Treatment Of Urinary Incontinence In Subjects With Neurogenic Detrusor Overactivity Due to Spinal Cord Injury or Multiple Sclerosis

Protocol #16-0644, No Longer Enrolling: 11/14/2019
Location: University of Colorado Hospital;

Evaluating the Tolerability and Safety Profile of Switching from Rituximab to Ocrelizumab: A Real World Evaluation of Patients with Relapsing Forms of Multiple Sclerosis

Principal Investigator: Donna Wilber
Protocol #16-1354, No Longer Enrolling: 12/12/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02980042

Phase III: UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE II STUDY)

Principal Investigator: Donna Wilber
Protocol #17-1170, No Longer Enrolling: 6/27/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03277248

A Randomized, Double-Blind, Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of FLX-787-ODT for Treatment of Muscle Cramps in Adult Subjects with Motor Neuron Disease

Protocol #17-1335, No Longer Enrolling: 10/1/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03196375

BEnefits of Stroke Treatment Delivered Using a Mobile Stroke Unit Compared to Standard Management by Emergency Medical Services: The BEST-MSU Study

Principal Investigator: Donna Wilber
Protocol #15-2114, No Longer Enrolling: 5/20/2021
Locations: Memorial Hospital Central; University of Colorado Hospital;

PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF OCTAGAM 10% IN PATIENTS WITH DERMATOMYOSITIS

Protocol #17-1396, No Longer Enrolling: 10/1/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02728752

Transcranial electrical stimulation for the treatment of cervical dystonia

Principal Investigator: Brian Berman
Protocol #17-1322, No Longer Enrolling: 10/12/2021
Locations: Colorado Research Center; Department Specific Free Standing Clinic;

Topiramate as a disease altering therapy for Cryptogenic Sensory Peripheral Neuropathy (CSPN)

Principal Investigator: Dianna Quan
Protocol #17-1751, No Longer Enrolling: 9/25/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02878798

Protocol I7S-MC-HBEH Effect of LY3154207 on Cognition in Mild-to-Moderate Parkinson's Disease Dementia (PDD) (The PRESENCE Study)

Principal Investigator: Donna Wilber
Protocol #17-1825, No Longer Enrolling: 2/22/2020
Location: University of Colorado Hospital;

Phase 2/3 Study of Arimoclomol in Inclusion Body Myositis (IBM)

Protocol #17-1854, No Longer Enrolling: 11/19/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02753530

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson's Disease

Principal Investigator: Donna Wilber
Protocol #17-1532, No Longer Enrolling: 10/20/2021
Locations: Outpatient CTRC; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03318523

Management of Acute Stroke Patients on Treatment with New Oral Anticoagulants: Addressing Realworld Anticoagulant Management Issues in Stroke (ARAMIS) Registry

The ARAMIS registry is designed to provide important and timely insight into the management of acute stroke patients who are on novel oral anticoagulant in community practice

Principal Investigator: Gerald McIntosh
Protocol #17-6111, No Longer Enrolling: 2/18/2020
Locations: Medical Center of the Rockies; Poudre Valley Hospital;

More information available at ClinicalTrials.gov: NCT02478177

A PHASE 2, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTIPLE DOSE STUDY OF CK-2127107 IN TWO ASCENDING DOSE COHORTS OF PATIENTS WITH SPINAL MUSCULAR ATROPHY (SMA)

Principal Investigator: Donna Wilber
Protocol #17-1816, No Longer Enrolling: 6/20/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02644668

Phase 2 Study of Allogeneic Umbilical Cord Blood Infusion for Adults with Ischemic Stroke - CoBIS 2

The primary objective of the study is to determine, in a randomized, placebo controlled trial, the efficacy of a single intravenous (IV) infusion of unrelated donor UCB for improving functional outcomes in patients with ischemic stroke. The secondary objectives are as follows: 1.To describe the safety and tolerability of a single IV infusion of unrelated donor UCB in patients with ischemic stroke 2.To evaluate the efficacy of a single IV infusion of unrelated donor UCB for improvement of neurological symptoms following ischemic stroke 3.To evaluate the efficacy of a single IV infusion of unrelated donor UCB for improvement in quality of life and emotional and cognitive status in patients with ischemic stroke

Principal Investigator: Daniel Vela Duarte
Protocol #17-2136, No Longer Enrolling: 5/20/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03004976

American Registry for Migraine Research

Principal Investigator: Donna Wilber
Protocol #17-2165, No Longer Enrolling: 5/11/2021
Locations: Lone Tree Medical Center; UCHealth Internal Medical Clinic - Lowry; University of Colorado Hospital;

A randomized, double blind, placebo-controlled parallel study of tolerability and efficacy of Cannabidiol (CBD) on tremor in Parkinson's disease

Principal Investigator: Donna Wilber
Protocol #17-2318, No Longer Enrolling: 11/20/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03582137

Long-term, prospective, multinational, parallel-cohort study monitoring safety in patients with MS newly started on fingolimod once daily or treated with another approved disease-modifying therapy

Principal Investigator: Donna Wilber
Protocol #15-0657, No Longer Enrolling: 2/27/2020
Location: University of Colorado Hospital;

AN OPEN-LABEL, MULTICENTER, BIOMARKER STUDY TO EXPLORE THE MECHANISM OF ACTION OF OCRELIZUMAB AND B-CELL BIOLOGY IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS OR PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS

Protocol #16-0120, No Longer Enrolling: 11/12/2019
Location: University of Colorado Hospital;

Determining the Optimal Treatment Strategy for Patients who have Chronic Migraine with Medication Overuse

Principal Investigator: Donna Wilber
Protocol #16-2179, No Longer Enrolling: 5/11/2021
Location: University of Colorado Hospital;

A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 2 Dose Regimens (Intravenous/Subcutaneous and Subcutaneous) of TEV-48125 versus Placebo for the Prevention of Episodic Cluster Headache

Protocol #17-0087, No Longer Enrolling: 11/6/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02945046

A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 2 Dose Regimens (Intravenous/Subcutaneous and Subcutaneous) of TEV-48125 versus Placebo for the Prevention of Chronic Cluster Headache

Protocol #17-0088, No Longer Enrolling: 10/1/2019
Location: University of Colorado Hospital;

A Proof of Concept Study to Investigate the Effect of IPT803 Adjunct Treatment in Patients with Parkinson's Disease

Principal Investigator: Brian Berman
Protocol #18-0113, No Longer Enrolling: 3/12/2020
Locations: Anschutz Health and Wellness; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03407378

Multiple-Biopsy of Infiltrative Glioma (M-BIG) Study

Principal Investigator: Elizabeth Chick
Protocol #17-2111, No Longer Enrolling: 4/15/2020
Location: Childrens Hospital Colorado;

Application of transcranial alternating current stimulation for modulation of sleep and cognitive performance

1).Optimize tACS parameters for duration, intensity and frequencies via utilization of EEG data recorded during tACS stimulation. 2)Determine whether recording artifacts introduced by tACS can confidently be removed from EEG signals. 3). Determine effects of tACS delivered with nested frequencies(multi-frequency signal) vs single frequency tACS, with regard to intrinsic EEG signal, for modulation of SWA coherence and power, as recorded in our overnight EEG sleep data. 4). Determine the cumulative effects of tACS delivered in multiple, consecutive nights on underlying EEG signals, sleep architecture, sleep quality and cognitive function among patients with MCI. 5). Determine if tACS is a viable treatment for disturbances of sleep and cognitive performance among patients with MCI. 6). Generate pilot data and manuscripts to support applications for larger randomized placebo-controlled clinical trials.

Principal Investigator: Brice Mcconnell
Protocol #16-1875, No Longer Enrolling: 5/5/2021
Locations: Colorado Research Center; Department Specific Free Standing Clinic; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03112902

Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS)

Principal Investigator: Donna Wilber
Protocol #15-2388, No Longer Enrolling: 11/13/2020
Location: University of Colorado Hospital;

AMPLATZERTM PFO Occluder Post Approval Study

Principal Investigator: Donna Wilber
Protocol #17-2334, No Longer Enrolling: 10/14/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03309332

A 3-ARM, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ADS-5102 AMANTADINE EXTENDED RELEASE CAPSULES IN MULTIPLE SCLEROSIS PATIENTS WITH WALKING IMPAIRMENT

Principal Investigator: Donna Wilber
Protocol #18-0375, No Longer Enrolling: 12/20/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03436199

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies

Principal Investigator: Donna Wilber
Protocol #18-0482, No Longer Enrolling: 4/25/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03222973

Multicenter, randomized, double-blind, parallel-group, add-on, superiority study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera?)

Protocol #16-2178, No Longer Enrolling: 10/1/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02907177

The Role Of Th40 Cells In Multiple Sclerosis And Type 1 Diabetes Subjects

Protocol #08-0613, No Longer Enrolling: 10/1/2019
Location: University of Colorado Hospital;

AN OPEN-LABEL, MULTI-CENTER, FOLLOW-UP STUDY DESIGNED TO EVALUATE THE LONG-TERM EFFECTS OF AP-CD/LD IN FLUCTUATING PARKINSON'S DISEASE SUBJECTS WHO COMPLETED STUDY IN 11 004

Protocol #15-2351, No Longer Enrolling: 11/6/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02615873

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of ACE-083 in Patients with Facioscapulohumeral Muscular Dystrophy

Principal Investigator: Donna Wilber
Protocol #18-0787, No Longer Enrolling: 11/22/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02927080

A Randomized, Placebo Surgery Controlled, Double-blinded, Multi-center, Phase 2 Clinical Trial, Evaluating the Efficacy and Safety of VY-AADC02 in Advanced Parkinson's Disease with Motor Fluctuations

Study is double blind and placebo controlled.

Principal Investigator: Pamela David Gerecht
Protocol #18-0829, No Longer Enrolling: 5/10/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03562494

Multi-center, randomized, double-blinded assessment of Tecfidera? in extending the time to a first attack in radiologically isolated syndrome (RIS) (ARISE)

Principal Investigator: Donna Wilber
Protocol #16-0121, No Longer Enrolling: 1/6/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02739542

Timing of Facial Movements for Posed and Spontaneous Facial Expressions V:30Jan2018

Principal Investigator: Donna Wilber
Protocol #17-0599, No Longer Enrolling: 10/28/2020
Location: University of Colorado Hospital;

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of ACE-083 in Patients with Charcot-Marie-Tooth Disease Types 1 and X. 01Mar2018

Protocol #18-0996, No Longer Enrolling: 11/6/2019
Locations: Brain Imaging Center (BIC); Colorado Research Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03124459

Microburst VNS Therapy Feasibility Study in Patients with Refractory Epilepsy

Principal Investigator: Cornelia Drees
Protocol #18-0995, No Longer Enrolling: 6/10/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03446664

A PHASE IIIB, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF SHORTER INFUSIONS OF OCRELIZUMAB IN PATIENTS WITH PRIMARY PROGRESSIVE AND RELAPSING MULTIPLE SCLEROSIS

Protocol #18-1262, No Longer Enrolling: 11/6/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03606460

A Phase 2b/3 Prospective, Randomized, Double-Blind, Sham-Controlled Trial of VTS-270 (2-hydroxypropyl-a-cyclodextrin) in Subjects with Neurologic Manifestations of Niemann-Pick Type C1 (NPC1) Disease

Principal Investigator: Donna Wilber
Protocol #18-0997, No Longer Enrolling: 4/25/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02534844

A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients

Protocol #18-1592, No Longer Enrolling: 11/6/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03560739

Advanced Directives in Amyotrophic Lateral Sclerosis: Preferences and Circumstances Surrounding End-of-Life Decision Making

Protocol #17-2029, No Longer Enrolling: 11/14/2019
Location: University of Colorado Hospital;

A Phase III, Long-Term, Randomized, Double-blind, Placebo-controlled Trial of BHV-4157 in Adult Subjects with Spinocerebellar Ataxia

Principal Investigator: Donna Wilber
Protocol #18-1875, No Longer Enrolling: 12/4/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03701399

A RANDOMIZED CONTROLLED STUDY TO COMPARE THE SAFETY AND EFFICACY OF IPX203 WITH IMMEDIATE-RELEASE CARBIDOPA-LEVODOPA IN PARKINSON'S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS

Principal Investigator: Donna Wilber
Protocol #18-2047, No Longer Enrolling: 5/10/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03670953

Genomic Translation for ALS Care

Principal Investigator: Donna Wilber
Protocol #18-1768, No Longer Enrolling: 5/11/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02795897

An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis

Principal Investigator: Donna Wilber
Protocol #18-2059, No Longer Enrolling: 11/22/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03650114

Safety and Efficacy Study of Elezanumab (ABT-555) in Progressive Forms of Multiple Sclerosis

Principal Investigator: Amanda Piquet
Protocol #18-2152, No Longer Enrolling: 4/25/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03737812

Safety and Efficacy Study of Elezanumab (ABT-555) in Relapsing Forms of Multiple Sclerosis

Principal Investigator: Amanda Piquet
Protocol #18-2451, No Longer Enrolling: 4/25/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03737851

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis

Principal Investigator: Dianna Quan
Protocol #18-2341, No Longer Enrolling: 4/25/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03772587

A PHASE 1B, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY TO DETERMINE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF DNL201 IN SUBJECTS WITH PARKINSON'S DISEASE

Principal Investigator: Donna Wilber
Protocol #18-2423, No Longer Enrolling: 2/29/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03710707

HELIOS-A: A Phase 3 Global, Randomized, Open-label Study to Evaluate the Efficacy and Safety of ALN-TTRSC02 in Patients with Hereditary Transthyretin Amyloidosis (hATTR Amyloidosis)

Principal Investigator: Dianna Quan
Protocol #18-2237, No Longer Enrolling: 11/22/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03759379

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness

Protocol #18-2536, No Longer Enrolling: 11/6/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03669588

A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment

Principal Investigator: Donna Wilber
Protocol #18-2535, No Longer Enrolling: 11/22/2019
Locations: Brain Imaging Center (BIC); Colorado Research Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03689972

A MULTICENTER, OPEN-LABEL SAFETY AND EFFICACY STUDY OF ADS-5102 AMANTADINE EXTENDED RELEASE CAPSULES IN PATIENTS WITH MULTIPLE SCLEROSIS AND WALKING IMPAIRMENT

Principal Investigator: Donna Wilber
Protocol #19-0363, No Longer Enrolling: 4/25/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03567057

Detection and Risk in Early MS

Principal Investigator: Donna Wilber
Protocol #19-0393, No Longer Enrolling: 8/11/2021
Locations: Brain Imaging Center (BIC); University of Colorado Hospital;

Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion

Principal Investigator: Donna Wilber
Protocol #19-0025, No Longer Enrolling: 2/21/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03781167

A 14-Week, Double-Blind, Randomized, Three-Arm, Parallel Group Study to Assess the Efficacy and Safety of Two Doses of Pridopidine versus Placebo for the Treatment of Levodopa-Induced Dyskinesia in Patients with Parkinson's Disease (gLIDe)

Principal Investigator: Donna Wilber
Protocol #19-0478, No Longer Enrolling: 7/7/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03922711

A Phase 3, 4-week, Multicenter, Randomized, Double-blind, Placebocontrolled, Parallel-group Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure

Principal Investigator: Haley Steinert
Protocol #19-0414, No Longer Enrolling: 5/10/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03750552

Instrumentation of Huntington's Disease Motor Function Assessment

Principal Investigator: Jo Shattuck
Protocol #19-0212, No Longer Enrolling: 5/5/2021
Location: University of Colorado Hospital;

A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD˗9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure

Principal Investigator: Donna Wilber
Protocol #19-0520, No Longer Enrolling: 5/10/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03829657

An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis

Principal Investigator: Dianna Quan
Protocol #19-0150, No Longer Enrolling: 5/11/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03896295

An Open-Label Extension Study to Evaluate the Long-Term Effects of ACE-083 in Patients with Facioscapulohumeral Muscular Dystrophy (FSHD) Previously Enrolled in Study A083-02 and in Patients with Charcot-Marie Tooth (CMT) Disease Types 1 and X Previously Enrolled in Study A083-03

Protocol #19-0720, No Longer Enrolling: 11/14/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03943290

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naive Adult Patients With Generalized Myasthenia Gravis

Principal Investigator: Donna Wilber
Protocol #19-0772, No Longer Enrolling: 5/11/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03920293

Gamma band neural stimulation and its effects on resting state networks

Principal Investigator: Brian Berman
Protocol #19-1251, No Longer Enrolling: 5/5/2021
Locations: Brain Imaging Center (BIC); Department Specific Free Standing Clinic;

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING EFFICACY AND SAFETY OF ROZANOLIXIZUMAB IN ADULT PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS

Principal Investigator: Brianna Blume
Protocol #19-1597, No Longer Enrolling: 6/24/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03971422

Neurological Screening of Controls in an Age-Related Macular Degeneration Registry

Principal Investigator: Claire Miller
Protocol #19-1925, No Longer Enrolling: 9/14/2021
Location: University of Colorado Hospital;

A Double-Blind, Placebo-Controlled, Inpatient, Dose-Ranging Efficacy Study of Staccato Alprazolam (STAP-001) in Subjects with Epilepsy with a Predictable Seizure Pattern

Principal Investigator: Danielle McDermott
Protocol #19-1396, No Longer Enrolling: 2/7/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03478982

A Double-Blind, Placebo-Controlled 16-Week Study of the Cognitive Effects of the Oral P38 Alpha Kinase Inhibitor Neflamapimod in Dementia with Lewy Bodies (DLB)

Principal Investigator: Donna Wilber
Protocol #19-1599, No Longer Enrolling: 3/28/2020
Locations: Brain Imaging Center (BIC); University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04001517

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 as Adjunctive Therapy in Focal-onset Epilepsy

Principal Investigator: Donna Wilber
Protocol #19-1620, No Longer Enrolling: 4/6/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03796962

A RANDOMIZED, OPEN-LABEL EXTENSION STUDY TO INVESTIGATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF ROZANOLIXIZUMAB IN ADULT PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS

Principal Investigator: Donna Wilber
Protocol #19-1929, No Longer Enrolling: 5/13/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04124965

A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF SUBCUTANEOUS OCRELIZUMAB ADMINISTRATION IN PATIENTS WITH MULTIPLE SCLEROSIS

Principal Investigator: Amanda Piquet
Protocol #19-1040, No Longer Enrolling: 6/8/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03972306

AN OPEN-LABEL EXTENSION STUDY OF THE SAFETY AND CLINICAL UTILITY OF IPX203 IN PARKINSON'S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS

Principal Investigator: Donna Wilber
Protocol #19-1461, No Longer Enrolling: 3/17/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03877510

A Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (HYQVIA/HyQvia) and Immune Globulin Infusion (Human), 10% (GAMMAGARD LIQUID/KIOVIG) for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Principal Investigator: Donna Wilber
Protocol #19-1455, No Longer Enrolling: 6/10/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02549170

A Multi-center, Prospective, Longitudinal, Digital Assessment Study of Disease Progression in Subjects with Early, Untreated Parkinson Disease (PD)

Principal Investigator: Brian Berman
Protocol #19-0865, No Longer Enrolling: 5/10/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03681015

A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy, Safety and Tolerability of ABBV-951 to Oral Carbidopa/Levodopa in Advanced Parkinson's Disease Patients

Principal Investigator: Donna Wilber
Protocol #19-2897, No Longer Enrolling: 4/17/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04380142

An open-label, non-randomized trial to investigate the efficacy and safety of early versus delayed start of arimoclomol in patients with sporadic inclusion body myositis who have completed the IBM4809 trial

Principal Investigator: Donna Wilber
Protocol #19-1598, No Longer Enrolling: 5/11/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04049097

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated with Huntington's Disease

Principal Investigator: Donna Wilber
Protocol #19-1840, No Longer Enrolling: 6/10/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04102579

A Parallel Group Double-Blind Randomized Placebo-Controlled Study to Evaluate the Efficacy and Safety of Eptinezumab Administered Intravenously in Subjects Experiencing an Acute Attack of Migraine

Principal Investigator: Donna Wilber
Protocol #19-1505, No Longer Enrolling: 3/28/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04152083

A Phase 3, Multi-center, Open-label, Safety Study of Oral Edaravone Administered over 48 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS)

Principal Investigator: Donna Wilber
Protocol #19-2377, No Longer Enrolling: 5/11/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04577404

Feasibility of wearable eye tracking in dementia with Lewy bodies: A potential method of real-time detection of cognitive fluctuations

Principal Investigator: Samantha Holden
Protocol #20-0729, No Longer Enrolling: 5/5/2021
Locations: Brain Imaging Center (BIC); University of Colorado Hospital;

Phase 3b Open-Label, Multicenter, Safety Study of BIIB037 (aducanumab) in Subjects with Alzheimer's disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205

Principal Investigator: Augusto Miravalle
Protocol #20-0571, No Longer Enrolling: 5/7/2021
Locations: Brain Imaging Center (BIC); University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04241068

A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS)

Principal Investigator: Donna Wilber
Protocol #20-0404, No Longer Enrolling: 5/11/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04248465

Real-time Seizure identification with Unobtrusive Bio-potential Recording System

Principal Investigator: Donna Wilber
Protocol #19-2503, No Longer Enrolling: 5/5/2021
Location: University of Colorado Hospital;

A Phase 2, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of TAK-079 in Patients With Generalized Myasthenia Gravis

Principal Investigator: Dianna Quan
Protocol #20-0609, No Longer Enrolling: 11/13/2021
Locations: Outpatient CTRC; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04159805

AN OPEN-LABEL EXTENSION STUDY TO EVALUATE ROZANOLIXIZUMAB IN STUDY PARTICIPANTS WITH GENERALIZED MYASTHENIA GRAVIS

Principal Investigator: Brianna Blume
Protocol #20-2740, No Longer Enrolling: 6/24/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04650854

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects with Generalized Myasthenia Gravis

Principal Investigator: Brianna Blume
Protocol #21-2746, No Longer Enrolling: 9/16/2021
Locations: Outpatient CTRC; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04115293

RTOG 1008: A Randomized Phase II Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors

This is a clinical trial of cisplatin that will be administered by IV which is standard of care and radiation therapy that will be administered standard of care.

Principal Investigator: Chelsea Schaefer
Protocol #13-2078, No Longer Enrolling: 3/10/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT01220583

RTOG 1304/NSABP B-51/Endorsed Study: A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy

This is a clinical trial of radiation that will be administered after a lumpectomy, to the breast and lymph nodes or mastectomy, to the area where the breast used to be and lymph nodes. This is done to see if giving radiation as described above will help women live longer.

Principal Investigator: Chelsea Schaefer
Protocol #13-2454, No Longer Enrolling: 12/31/2020
Locations: Greeley Campus; Harmony Campus; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT01872975

103A-301: A Multicenter, Double-blind, Placebo-controlled, Adaptive Phase 3 Trial of POL-103A Polyvalent Melanoma Vaccine in Post-resection Melanoma Patients with a High Risk of Recurrence

This is a clinical trial of investigational drug POL-103A, which will be administered by injections (shots).

Principal Investigator: Karl Lewis
Protocol #12-1076, No Longer Enrolling: 8/20/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT01546571

Pilot Project to Evaluate Hyperglycemia and Glucose Variability in Cancer Patients Receiving Dexamethasone

Principal Investigator: CINDY O'BRYANT
Protocol #14-1764, No Longer Enrolling: 1/29/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02372539

NRG-BR002 A Phase IIR/III Trial of Standard of Care Therapy with or without Stereotactic Body Radiotherapy (SBRT) and/or Surgical Ablation for Newly Oligometastatic Breast Cancer

This is a clinical trial of standard of care and SBRT that will be administered by radiotherapy and is investigational.

Protocol #15-0136, No Longer Enrolling: 10/1/2019
Locations: Greeley Hospital; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Poudre Valley Hospital; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02364557

Perioperative Therapy for Resectable and Borderline Resectable Pancreatic Adenocarcinoma with Molecular Correlates

Principal Investigator: Anne Martin
Protocol #15-0150, No Longer Enrolling: 6/8/2021
Locations: Dana Farber Cancer Institute; Lone Tree Medical Center; Mayo Clinic, Arizona; New York University; University of Arizona Cancer Center; University of Colorado Hospital; University of Kansas Cancer Center;

More information available at ClinicalTrials.gov: NCT02723331

ML28897/PRO 02 MY PATHWAY: An Open-Label Phase IIA Study Evaluating Trastuzumab/Pertuzumab, Erlotinib, Vemurafenib/Cobimetinib, Vismodegib, Alectinib, and Atezolizumab in Patients who have Advanced Solid Tumors with Mutations or Gene Expression Abnormalities Predictive of Response to One of these Agents

Principal Investigator: Daniel Bowles
Protocol #15-0801, No Longer Enrolling: 9/4/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02091141

AEWS1221 Randomized Phase II Trial Evaluating the Addition of the IGF-1R Monoclonal Antibody Ganitumab (AMG 479, NSC# 75008, IND# 120449) to Multiagent Chemotherapy for Patients with Newly Diagnosed Metastatic Ewing Sarcoma

Principal Investigator: Tim Garrington
Protocol #15-1618, No Longer Enrolling: 5/22/2020
;

More information available at ClinicalTrials.gov: NCT02306161

RXDX-101-02 An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients with Locally Advanced or Metastatic Solid Tumors that Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangement

Principal Investigator: Chelsea Mason
Protocol #15-1574, No Longer Enrolling: 1/8/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02568267

EZH-102 A Phase I Study of the EZH2 Inhibitor Tazemetostat in Pediatric Subjects with Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma

Principal Investigator: Carmen Rivera
Protocol #15-1825, No Longer Enrolling: 6/29/2021
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT02601937

MLN0128 A Phase Ib Study of the Combination of MLN0128 (Dual TORC I/2 Inhibitor) and MLN8237 (Aurora A Inhibitor, Alisertib) in Patients with Advanced Solid Tumors with an Expansion Cohort in Metastatic Triple-Negative Breast Cancer (TNBC)

Principal Investigator: Jennifer Diamond
Protocol #15-1135, No Longer Enrolling: 3/19/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02719691

RU2413061 Randomized, Double-Blind, Phase II Study of Radioactive Iodine (RAI) in Combination with Placebo or Selumetinib for the Treatment of RAI-Avid Recurrent/Metastatic Thyroid Cancers

Principal Investigator: Daniel Bowles
Protocol #15-1932, No Longer Enrolling: 2/26/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02393690

I5B-MC-JGDL A Phase 1b (Open-Label)/Phase 2 (Randomized, Double-Blinded) Study evaluating Gemcitabine and Docetaxel With or Without Olaratumab in the Treatment of Advanced Soft Tissue Sarcoma

Principal Investigator: Victor Villalobos
Protocol #15-1995, No Longer Enrolling: 11/27/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02659020

MK-3475-158-00 A Clinical Trial of Pembrolizumab (MK-3475) Evaluating Predictive Biomarkers in Subjects with Advanced Solid Tumors

Protocol #15-2301, No Longer Enrolling: 11/8/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02628067

AP32788-15-101 A Phase I/2 Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of the Oral EGFR/HER2 Inhibitor TAK-788 (AP32788) in Non-Small Cell Lung Cancer

1. To determine the safety profile of orally administered AP32788 2. To identify the RP2D, dose-limiting toxicities (DLTs), and the maximum tolerated dose (MTD) of AP32788 3 .To determine the pharmacokinetic (PK) profile of AP32788 and its active metabolites, AP32960 and AP32914 4. To evaluate the anti-tumor activity of AP32788 in NSCLC patients with EGFR or HER2 mutations 5. To explore associations between tumor and plasma biomarkers and AP32788 efficacy and safety

Principal Investigator: Molly Throdahl
Protocol #16-0208, No Longer Enrolling: 2/14/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02716116

ANHL12P1 A Randomized Phase II Trial of Brentuximab Vedotin (SGN35, NSC# 749710) or Crizotinib (NSC# 749005, commercially labeled) in Combination with Chemotherapy for Newly Diagnosed Patients with Anaplastic Large Cell Lymphoma (ALCL) IND#117117

Principal Investigator: KELLY MALONEY
Protocol #15-1921, No Longer Enrolling: 9/14/2021
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT01979536

INTense Exercise foR surviVAL among Men with Metastatic Prostate Cancer (INTERVAL GAP4): A Multicenter, Randomised, Controlled Phase III Study

A comparison of exercise versus no exercise in men with Metastatic Castrate-Resistant Prostate Cancer.

Principal Investigator: Daniel Heck
Protocol #16-0227, No Longer Enrolling: 10/1/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02730338

D419NC00001 A Phase 1/2 Study of Durvalumab and Monalizumab in Adult Subjects with Select Advanced Solid Tumors

Principal Investigator: CHALAUNDA SCOTT
Protocol #16-0207, No Longer Enrolling: 7/31/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02671435

NRG-GY006: A Randomized Phase III Trial of Radiation Therapy and Cisplatin Alone or in Combination with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer

Principal Investigator: Jenna Buehler
Protocol #16-0493, No Longer Enrolling: 8/13/2021
Locations: Lone Tree Medical Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02466971

LCCC 1523: Phase 2 Trial of Brigatinib after Treatment with Next-Generation ALK inhibitors in Refractory ALK Rearranged NSCLC

Principal Investigator: Nicole Conti
Protocol #16-0506, No Longer Enrolling: 9/30/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02706626

KCP-9274-901 A Phase 1 Open-label Study of the Safety, Tolerability and Efficacy of KPT-9274, a Dual Inhibitor of PAK4 and NAMPT, in Patients with Advanced Solid Malignancies or Non-Hodgkin's Lymphoma

Principal Investigator: Jennifer Diamond
Protocol #16-0628, No Longer Enrolling: 7/10/2020
Locations: Lone Tree Medical Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02702492

NRG-GY005: A Randomized Phase II/III Study of the Combination of Cediranib and Olaparib Compared to Cediranib or Olaparib Alone, or Standard of Care Chemotherapy in Women with Recurrent Platinum-Resistant or -Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (COCOS)

Principal Investigator: Jenna Buehler
Protocol #16-0708, No Longer Enrolling: 10/6/2020
Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02502266

Molecular Profiling-based Assignment of Cancer Therapy for Patients with Advanced Solid Tumors (MPACT)

Principal Investigator: Andrea Glass
Protocol #16-1057, No Longer Enrolling: 7/15/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT01827384

Randomized Phase II trial of preoperative fulvestrant with or without enzalutamide in ER+/Her2- breast cancer

Principal Investigator: Anthony Elias
Protocol #16-1042, No Longer Enrolling: 9/9/2021
Locations: Highlands Ranch Hospital; Lone Tree Medical Center; Memorial Sloan Kettering Cancer Center; University of Colorado Hospital; West Cancer Center;

More information available at ClinicalTrials.gov: NCT02955394

MAINTENANCE OBINUTUZUMAB FOR PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA COMPLETE OR PARTIAL RESPONDERS

Principal Investigator: Aubrey Dedin
Protocol #16-1217, No Longer Enrolling: 10/27/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02498951

A Phase 1b Study of Navicixizumab (OMP-305B83) plus Weekly Paclitaxel in Subjects with Platinum Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancer

Protocol #16-1225, No Longer Enrolling: 11/12/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03030287

EA5142 Adjuvant Nivolumab in Resected Lung Cancers (ANVIL) A Randomized Phase III Study of Nivolumab After Surgical Resection and Adjuvant Chemotherapy in Non-Small Cell Lung Cancers

Protocol #16-1241, No Longer Enrolling: 10/4/2019
Locations: Greeley Hospital; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02595944

Phase l-ll Study of MEK 162 for Children with Low-Grade Gliomas and Other Ras/Raf/ERK Pathway Activated Tumors

Principal Investigator: Carmen Rivera
Protocol #16-1205, No Longer Enrolling: 12/17/2020
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT02285439

A Phase 2 Efficacy and Safety Study of Niraparib in Men with Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies

To establish safety and efficacy of Niraparib in patients with targeted DNA- repair anomalies

Principal Investigator: Michael Wacker
Protocol #16-1470, No Longer Enrolling: 4/9/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02854436

A Phase 2, Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

A rollover study to continue to document patients previously enrolled to an enzalutamide study

Principal Investigator: Elaine Lam
Protocol #16-1640, No Longer Enrolling: 5/28/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02960022

Aflac ST 1501: Abemaciclib in Children with Newly Diagnosed Diffuse Intrinsic Pontine Glioma, and in Children with Recurrent and Refractory Solid Tumors Including Malignant Brain Tumors

Principal Investigator: Carmen Rivera
Protocol #16-1825, No Longer Enrolling: 8/7/2020
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT02644460

A Randomized Phase 2 Trial of Cisplatin/Gemcitabine with or without M6620 (VX-970) in Metastatic Urothelial Carcinoma

A comparison of Gem/Cis +/- VX-970

Principal Investigator: Mary Anduha
Protocol #16-1951, No Longer Enrolling: 12/31/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02567409

A PHASE III, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY OF ATEZOLIZUMAB (ANTI-PD-L1 ANTIBODY) AS ADJUVANT THERAPY IN PATIENTS WITH RENAL CELL CARCINOMA AT HIGH RISK OF DEVELOPING METASTASIS FOLLOWING NEPHRECTOMY

Atezolizumab vs. placebo as adjuvant therapy post nephrectomy

Protocol #16-1420, No Longer Enrolling: 10/28/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03024996

An Open-Label Study of Brentuximab Vedotin+Adriamycin, Vinblastine, and Dacarbazine in Pediatric Patients With Advanced Stage Newly Diagnosed Hodgkin Lymphoma

Principal Investigator: Anna Franklin
Protocol #16-2269, No Longer Enrolling: 2/9/2021
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT02979522

ARM Study: A phase II trial to evaluate crizotinib in the neoadjuvant setting in non-small cell lung cancer patients with surgically resectable, ALK, ROS1, or MET-oncogene positive non-small cell lung cancer

Principal Investigator: ANDREA MARTINSEN
Protocol #16-2025, No Longer Enrolling: 9/23/2020
Locations: Lone Tree Medical Center; University of California San Francisco; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03088930

Combination Targeted Therapy with Pembrolizumab and Lenvatinib in Progressive, Radioiodine-Refractory Differentiated Thyroid Cancers: A Phase II Study

Principal Investigator: Daniel Bowles
Protocol #16-2230, No Longer Enrolling: 3/31/2020
Locations: Dana Farber Cancer Institute; MD Anderson Cancer Center; Memorial Sloan Kettering Cancer Center; The Ohio State University Comprehensive Cancer Center; UCLA, Jonsson Cancer Center; University of Colorado Hospital; University of Michigan Comprehensive Cancer Center;

More information available at ClinicalTrials.gov: NCT02973997

Phase I/II Study of Pembrolizumab and Cabozantinib in Patients with Metastatic Renal Cell Carcinoma

To assess the efficacy of Prmbrolizumab plus Cabozantinib in patients with metastatic renal cell carcinoma

Principal Investigator: Anne Martin
Protocol #16-2300, No Longer Enrolling: 12/19/2020
Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03149822

CA018003: A Phase 2, Fast Real-time Assessment of Combination Therapies in Immuno-ONcology Study in Participants with Advanced Gastric Cancer (FRACTION-Gastric Cancer)

Principal Investigator: Meredith Waring
Protocol #16-2449, No Longer Enrolling: 4/27/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02935634

A PHASE 1, DOSE ESCALATION STUDY OF ALX148 IN PATIENTS WITH ADVANCED SOLID TUMORS AND LYMPHOMA

Principal Investigator: Sheri Neu
Protocol #16-2248, No Longer Enrolling: 2/24/2021
Locations: Lone Tree Medical Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03013218

A Multi-Center, Open label, Dose Escalation, Phase I/Ib Study to Evaluate the Safety and Efficacy of RP4010, a Calcium Release Activated Calcium (CRAC) Channel Inhibitor, in Patients with Relapsed or Refractory Lymphomas

Protocol #17-0029, No Longer Enrolling: 10/1/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03119467

A PHASE 2 STUDY OF REGN2810, A FULLY HUMAN MONOCLONAL ANTIBODY TO PROGRAMMED DEATH-1, IN PATIENTS WITH ADVANCED BASAL CELL CARCINOMA WHO EXPERIENCED PROGRESSION OF DISEASE ON HEDGEHOG PATHWAY INHIBITOR THERAPY, OR WERE INTOLERANT OF PRIOR HEDGEHOG PATHWAY INHIBITOR THERAPY

Principal Investigator: Karl Lewis
Protocol #16-2696, No Longer Enrolling: 12/24/2020
Locations: Lone Tree Medical Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03132636

A Multicenter Phase 1, Open-Label Study of DCC-3014 to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Patients with Advanced Tumors

Principal Investigator: Stephen Leong
Protocol #16-2407, No Longer Enrolling: 4/11/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03069469

A Phase I/II, Open-Label, Multicenter, Dose Escalation and Efficacy Study of mRNA-2416, a Lipid Nanoparticle Encapsulated mRNA Encoding Human OX40L, for Intratumoral Injection to Patients with Advanced Malignancies

Principal Investigator: Ana Nguyen
Protocol #17-0074, No Longer Enrolling: 7/2/2021
Locations: Lone Tree Medical Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03323398

S1609, DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors

Principal Investigator: Sarah Davis
Protocol #17-0280, No Longer Enrolling: 10/23/2020
Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02834013

Lenalidomide and Dexamethasone (Rd) versus Clarithromycin (Biaxin) /Lenalidomide (Revlimid) / Dexamethasone (BiRd) as Initial Therapy in Multiple Myeloma

Principal Investigator: Derek Schatz
Protocol #17-7836, No Longer Enrolling: 12/17/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02516696

EA8143: A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients with Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)

A comparison of Nivolumab vs no Nivolumab prior to nephrectomy.

Principal Investigator: Geetika Srivastava
Protocol #17-0406, No Longer Enrolling: 11/25/2020
Locations: Greeley Campus; Harmony Campus; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03055013

A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAB001 in Subjects with Advanced Malignancies

Principal Investigator: Anthony Elias
Protocol #17-0402, No Longer Enrolling: 9/11/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03474640

A PHASE 1/2, OPEN-LABEL, MULTICENTER STUDY OF THE COMBINATION OF NKTR-214 AND NIVOLUMAB OR THE COMBINATION OF NKTR-214, NIVOLUMAB, AND OTHER ANTI-CANCER THERAPIES IN PATIENTS WITH SELECT LOCALLY ADVANCED OR METASTATIC SOLID TUMOR MALIGNANCIES

Principal Investigator: Carolyn Dilz
Protocol #17-0491, No Longer Enrolling: 2/7/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02983045

EA2161: A Phase II Study of MLN0128 (TAK-228) in Rapalog-Resistant Advanced Pancreatic Neuroendocrine Tumors (PNET)

Principal Investigator: Rachel Telles
Protocol #17-0614, No Longer Enrolling: 1/3/2020
Locations: Greeley Hospital; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Poudre Valley Hospital; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02893930

A PHASE Ib/II STUDY EVALUATING THE SAFETY AND EFFICACY OF OBINUTUZUMAB IN COMBINATION WITH IDASANUTLIN AND ENETOCLAX IN PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA AND OBINUTUZUMAB OR RITUXIMAB IN COMBINATION WITH IDASANUTLIN AND VENETOCLAX IN PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA

Protocol #17-0173, No Longer Enrolling: 10/1/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03135262

CA209744: Risk-based, response-adapted, Phase II open-label trial of nivolumab + brentuximab vedotin (N + Bv) for children, adolescents, and young adults with relapsed/refractory (R/R) CD30 + classic Hodgkin lymphoma (cHL) after failure of first-line therapy, followed by brentuximab + bendamustine (Bv + B) for participants with a suboptimal response.

Principal Investigator: Anna Franklin
Protocol #17-0401, No Longer Enrolling: 7/10/2021
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT02927769

NRG-LU002: Maintenance Systemic Therapy Versus Local Consolidative Therapy (LCT) Plus Maintenance Systemic Therapy for Limited Metastatic Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II/III Trial

Principal Investigator: Caralyn Henderson
Protocol #17-0828, No Longer Enrolling: 5/14/2020
Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital;

More information available at ClinicalTrials.gov: NCT03137771

A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-022, an anti-TIM-3 Monoclonal Antibody, in Patients with Advanced Solid Tumors

Protocol #17-0767, No Longer Enrolling: 10/25/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02817633

A Phase I Trial of MK-7684 as Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

Principal Investigator: AMANDA KUPNIEWSKI
Protocol #17-0948, No Longer Enrolling: 5/19/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02964013

A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared with Investigator's Choice in HLA-A*0201 Positive Patients with Previously Untreated Advanced Uveal Melanoma

Principal Investigator: Karl Lewis
Protocol #17-0996, No Longer Enrolling: 12/29/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03070392

A Phase 3, Randomized, Open-Label Study of Nivolumab Combined with Cabozantinib versus Sunitinib in Participants with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma. Version Amendment 1 v2.0 dated 12/18/17

A comparison of Nivolumab + cabozantinib vs Nivolumab + Ipilimumab + Cabozantinib vs Sunitinb in patients with kidney cancer

Protocol #17-1121, No Longer Enrolling: 10/17/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03141177

Phase I Trial of Arsenic Trioxide with Cyclophosphamide in Patients with Relapsed/Refractory Acute Myeloid Leukemia

Principal Investigator: Dan Pollyea
Protocol #17-0754, No Longer Enrolling: 1/16/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03318016

A Phase 1b/2 Study of BMS-813160 in Combination with Chemotherapy or Nivolumab in Patients with Advanced Solid Tumors

Principal Investigator: Matthew Lee
Protocol #17-1167, No Longer Enrolling: 2/8/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03184870

ADVL1622: Phase 2 Trial of XL184 (Cabozantinib) an Oral Small-Molecule Inhibitor of Multiple Kinases, in Children and Young Adults with Refractory Sarcomas, Wilms Tumor, and Other Rare Tumors

Principal Investigator: Carmen Rivera
Protocol #17-1045, No Longer Enrolling: 10/27/2020
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT02867592

Azacitidine and Venetoclax (ABT-199) as Induction Therapy with Venetoclax Maintenance in Previously Untreated Elderly Patients with Acute Myeloid Leukemia

Principal Investigator: Dan Pollyea
Protocol #17-7821, No Longer Enrolling: 2/6/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03466294

A Phase 1/1b/2a, 3-Part, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Ascending Doses of AZD5991 Monotherapy and in Combination with Venetoclax in Subjects with Relapsed or Refractory Haematologic Malignancies

Principal Investigator: Derek Schatz
Protocol #17-0900, No Longer Enrolling: 3/28/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03218683

A Phase I Study of Stereotactic Body Radiation Therapy for Patients with Limited Locoregional Recurrences of Ovarian and Uterine Serous Carcinoma

Principal Investigator: Christine Fisher
Protocol #17-1333, No Longer Enrolling: 10/8/2020
Locations: Lone Tree Medical Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03325634

PROSPECTIVE, LONGITUDINAL, NON-INTERVENTIONAL STUDY OF DISEASE BURDEN AND TREATMENT OF PATIENTS WITH LOW-RISK MYELOFIBROSIS (MF) OR HIGH-RISK ESSENTIAL THROMBOCYTHEMIA (ET) OR ET PATIENTS RECEIVING ET-DIRECTED THERAPY

Principal Investigator: Alicia Deschaine
Protocol #17-6155, No Longer Enrolling: 7/8/2021
Location: Memorial Hospital Central;

More information available at ClinicalTrials.gov: NCT02953704

CANscript Clinical outcomEs in a Real-world Setting (ANCERS)-2: A prospective, multicenter, observational study examining the clinical utility of CANscript in routine clinical practice

Protocol #17-0694, No Longer Enrolling: 11/14/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03253575

ADVL1514: A Phase I Study of ABI-009 (Nab-Rapamycin) in Pediatric Patients With Recurrent or Refractory Solid Tumors, Including CNS Tumors as a Single Agent and in Combination with Temozolomide and Irinotecan

Principal Investigator: Carmen Rivera
Protocol #17-1376, No Longer Enrolling: 8/19/2021
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT02975882

A Phase I, Open-Label, Multicenter Study of the Safety and Efficacy of MIW815 (ADU-S100) Administered by Intratumoral Injection to Patients with Advanced/Metastatic Solid Tumors or Lymphomas

Principal Investigator: Ana Nguyen
Protocol #17-1452, No Longer Enrolling: 12/14/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02675439

An International, Multi-Center, Open-Label, Randomized, Phase III Trial of Sacituzumab Govitecan versus Treatment of Physician Choice in Patients with Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Treatments

Protocol #17-1501, No Longer Enrolling: 10/28/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02574455

A Phase 2, Multicenter Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Treatment of Patients with Metastatic Melanoma

Principal Investigator: Karl Lewis
Protocol #17-1474, No Longer Enrolling: 2/9/2021
Locations: Lone Tree Medical Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02360579

A Phase 1b Multi-cohort Study of the Combination of Pembrolizumab (MK-3475) plus Binimetinib alone or the Combination of Pembrolizumab plus Chemotherapy with or without Binimetinib in Participants with Metastatic Colorectal Cancer (KEYNOTE-651)

Principal Investigator: Chris Lieu
Protocol #17-1021, No Longer Enrolling: 9/16/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03374254

A Phase I/Ib Study of sEphB4-HSA in Combination with Chemotherapy or Cetuximab and Radiation Therapy in Patients with Intermediate to High Risk, Locally-Advanced Squamous Cell Carcinomas of the Head and Neck

Principal Investigator: Jillian Welker
Protocol #16-2575, No Longer Enrolling: 6/23/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04091867

PBTC-029: A Phase I and Phase II Re-Treatment Study of AZD6244 for Recurrent or Refractory Pediatric Low Grade Glioma

Principal Investigator: Carmen Rivera
Protocol #17-1790, No Longer Enrolling: 1/8/2021
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT01089101

Phase II open-label global study to evaluate the effect of dabrafenib in combination with trametinib in children and adolescent patients with BRAF V600 mutation positive Low Grade Glioma (LGG) or relapsed or refractory High Grade Glioma (HGG)

Principal Investigator: Carmen Rivera
Protocol #17-1406, No Longer Enrolling: 4/21/2021
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT02684058

TACL 2016-003: Epigenetic Reprogramming in Relapse AML: A Phase I Study of Decitabine and Vorinostat Followed by Fludarabine, Cytarabine and G-CSF (FLAG) in Children and Young Adults with Relapsed/Refractory AML

Principal Investigator: Anna Franklin
Protocol #17-1777, No Longer Enrolling: 7/10/2020
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT03263936

A Phase II Study of TAK-228 in patients with previously treated metastatic renal cell carcinoma

Assessment of TAK 228 in metastatic kidney cancer

Principal Investigator: Elaine Lam
Protocol #17-0727, No Longer Enrolling: 2/12/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03097328

COG AALL15P1 - A Groupwide Pilot Study to Test the Tolerability and Biologic Activity of the Addition of Azacitidine (IND# 133688, NSC# 102816) to Chemotherapy in Infants with Acute Lymphoblastic Leukemia (ALL) and KMT2A (MLL) Gene Rearrangement

Principal Investigator: Joanne Hilden
Protocol #17-0619, No Longer Enrolling: 6/24/2020
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT02828358

S1616, A Phase II Randomized Study of Nivolumab (NSC-748726) with Ipilimumab (NSC-732442) OR Ipilimumab Alone in Advanced Melanoma Patients Refractory to an Anti-PD-1 or Anti-PD-L1 Agent

Principal Investigator: Sarah Tarver
Protocol #17-1834, No Longer Enrolling: 8/13/2020
Locations: Greeley Campus; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital;

More information available at ClinicalTrials.gov: NCT03033576

A Multiarm, Open-label, Multicenter, Phase 1b/2 Study to Evaluate Novel Combination Therapies in Subjects with Previously Treated Advanced EGFRm NSCLC

Principal Investigator: ANDREA MARTINSEN
Protocol #17-1757, No Longer Enrolling: 6/6/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03381274

An Open-Label, Non-Randomized, Multicenter Study to Determine the Pharmacokinetics and Safety of Niraparib Following A Single Oral Dose in Patients with Advanced Solid Tumors and Either Normal Hepatic Function or Moderate Hepatic Impairment

Principal Investigator: Ana Nguyen
Protocol #17-1943, No Longer Enrolling: 7/10/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03359850

PD-1 Immune Checkpoint Inhibition for the Reversal of Squamous Dysplasia in High Risk Current and Former Smokers with or without a History a Lung Cancer

Subjects will receive treatment with nivolumab as a 30 minute IV infusion on Day 1 of a treatment cycle every two weeks (14 days). There will be no dose escalations or reductions allowed. Treatment may be delayed for up to a maximum of 2 weeks from the scheduled re-treatment date. Subjects may be dosed no less than 12 days from the previous dose.

Principal Investigator: Brandi Kubala
Protocol #17-1492, No Longer Enrolling: 11/17/2021
Locations: Rocky Mountain Regional VA Medical Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03347838

Open-label, Randomized, Controlled, Phase 3 Safety and Efficacy Study of Trans Sodium Crocetinate (TSC) with Radiation Therapy and Temozolomide in Newly Diagnosed Glioblastoma (GBM) Biopsy-Only Subjects

Principal Investigator: Aislinn Lederman
Protocol #17-1974, No Longer Enrolling: 12/11/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03393000

TACL 2016-001: A Randomized, Open-label, Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Patients With Relapsed or Refractory Mature B-cell non-Hodgkin Lymphoma

Principal Investigator: Anna Franklin
Protocol #17-1481, No Longer Enrolling: 8/15/2020
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT02703272

An Open-Label Phase 2 Study of Itacitinib (INCB039110) in Combination With Low-Dose Ruxolitinib or Itacitinib Alone Following Ruxolitinib in Subjects With Myelofibrosis

Principal Investigator: Brandon McMahon
Protocol #17-2086, No Longer Enrolling: 2/26/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03144687

Identifying Biomarkers of Immune-Related Toxicity in Cancer Patients Treated with Immune Checkpoint Inhibitors; A Pilot Project

Principal Investigator: Sarah Davis
Protocol #17-1940, No Longer Enrolling: 12/6/2019
Locations: Rocky Mountain Regional VA Medical Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03409016

S1613: A RANDOMIZED PHASE II STUDY OF TRASTUZUMAB AND PERTUZUMAB (TP) COMPARED TO CETUXIMAB AND IRINOTECAN (CETIRI) IN ADVANCED/METASTATIC COLORECTAL CANCER (MCRC) WITH HER-2 AMPLIFICATION

Principal Investigator: Amanda Siedem
Protocol #17-2125, No Longer Enrolling: 8/11/2021
Locations: Greeley Campus; Highlands Ranch Hospital; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03365882

Open label, Phase I/II study to evaluate pharmacokinetics, pharmacodynamics, safety, and anticancer activity of avelumab in pediatric subjects from birth to less than 18 years of age with refractory or relapsed solid tumors and lymphoma (Merck-Serono Protocol MS100070-0306

Principal Investigator: Carmen Rivera
Protocol #17-1845, No Longer Enrolling: 8/27/2020
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT03451825

A Phase 1/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination with Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558)in Advanced Solid Tumors.

Principal Investigator: Karl Lewis
Protocol #17-2164, No Longer Enrolling: 8/4/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT01968109

A Phase I Study of the Wee 1 kinase (Wee 1) inhibitor AZD1775 in combination with Radiotherapy and Cisplatin in Cervical, Upper Vaginal and Uterine Cancers (10041848, 10008224, 10008238, 10046888, 10014735)

Principal Investigator: AMANDA KUPNIEWSKI
Protocol #17-2198, No Longer Enrolling: 7/21/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03345784

A Phase 2 Study of Cabiralizumab (BMS-986227, FPA008) Administered in Combination with Nivolumab (BMS-936558) with and without Chemotherapy in Patients with Advanced Pancreatic Cancer

Principal Investigator: Rachel Telles
Protocol #17-2189, No Longer Enrolling: 3/28/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03336216

PBTC-039: Phase II study of Peginterferon alfa-2b (SYLATRON) for pediatric patients with unresectable or recurrent craniopharyngioma

Principal Investigator: Carmen Rivera
Protocol #17-2257, No Longer Enrolling: 11/18/2020
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT01964300

A Phase 1/2 Dose Escalation and Dose Expansion Study of BA3011 Alone and in Combination with Nivolumab in Adult and Adolescent Patients 12 Years and Older in Patients with Advanced Solid Tumors

Principal Investigator: Chelsea Mason
Protocol #17-2450, No Longer Enrolling: 8/21/2020
Locations: Lone Tree Medical Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03425279

A PHASE 1B, OPEN LABEL, MULTI-CENTER TRIAL OF AB-110 IN ADULTS WITH HEMATOLOGIC MALIGNANCIES UNDERGOING CORD BLOOD TRANSPLANTATION

A PHASE 1B, OPEN LABEL, MULTI-CENTER TRIAL OF AB-110 IN ADULTS WITH HEMATOLOGIC MALIGNANCIES UNDERGOING CORD BLOOD TRANSPLANTATIONTo assess the safety of infusing AB-110, cord blood (CB) hematopoietic stem and progenitor cells (HSPCs) with engineered human umbilical vein endothelial cells.

Principal Investigator: Derek Schatz
Protocol #17-2078, No Longer Enrolling: 7/15/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03483324

A Phase I Trial of AZD9291 and Necitumumab in EGFR-Mutant Non-Small Cell Lung Cancer After Progression on a Previous EGFR Tyrosine Kinase Inhibitor

Principal Investigator: Ana Nguyen
Protocol #17-2381, No Longer Enrolling: 10/9/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02496663

An Open-Label, Dose Escalation, Phase 1, First-in-Human Study of TAK-164, an Antibody-Drug Conjugate, in Patients with Advanced Gastrointestinal Cancers Expressing Guanylyl Cyclase C

Principal Investigator: Alexis Leal
Protocol #17-2226, No Longer Enrolling: 3/19/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03449030

First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of Axl-specific antibody-drug conjugate (enapotamab vedotin, HuMax-AXL-ADC) in patients with solid tumors

Principal Investigator: Erin Schenk
Protocol #17-2451, No Longer Enrolling: 9/4/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02988817

A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination with Nivolumab in Advanced Solid Tumors

Principal Investigator: Andrew Coy
Protocol #18-0033, No Longer Enrolling: 9/11/2020
Locations: Lone Tree Medical Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03369223

A Phase 1b/2a Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination with Avelumab

Principal Investigator: CHALAUNDA SCOTT
Protocol #18-0187, No Longer Enrolling: 10/29/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03409458

A PHASE Ia/Ib, MULTICENTER, OPEN-LABEL, DOSE ESCALATION, DOSE EXPANSION STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF GDC-9545 ALONE OR IN COMBINATION WITH PALBOCICLIB AND/OR LHRH AGONIST IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ESTROGEN RECEPTOR POSITIVE BREAST CANCER

Principal Investigator: Gwendolyn Wade
Protocol #17-2208, No Longer Enrolling: 2/17/2021
Locations: Lone Tree Medical Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03332797

ADVL1615: A Phase I Study of Pevonedistat (MLN4924, IND# 136078), a NEDD8 Activating Enzyme (NAE) Inhibitor, in Combination with Temozolomide and Irinotecan in Pediatric Patients with Recurrent or Refractory Solid Tumors

Principal Investigator: Carmen Rivera
Protocol #18-0017, No Longer Enrolling: 4/21/2021
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT03323034

ADVL1614: A Phase I/II Study of VX15/2503 (IND# 136181) in Children, Adolescents, or Young Adults with Recurrent or Relapsed Solid Tumors

Principal Investigator: Carmen Rivera
Protocol #18-0320, No Longer Enrolling: 6/5/2020
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT03320330

Phase II study of pembrolizumab in combination with binimetinib and bevacizumab in patients with refractory colorectal cancer

Principal Investigator: Anne Martin
Protocol #17-0466, No Longer Enrolling: 9/29/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03475004

A Phase 1/2 Study of Relatlimab (anti-LAG-3 Monoclonal Antibody) Administered in Combination with Both Nivolumab (anti-PD-1 Monoclonal Antibody) and BMS- 986205 (IDO1 inhibitor) or in Combination with Both Nivolumab and Ipilimumab (anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors

Principal Investigator: AMANDA KUPNIEWSKI
Protocol #18-0154, No Longer Enrolling: 4/25/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03459222

Open-label Phase 1 Study to Evaluate Drug-Drug Interactions of Agents Co-Administered with Encorafenib and Binimetinib in Patients with BRAF V600-mutant Unresectable or Metastatic Melanoma or Other Advanced Solid Tumors

Principal Investigator: Karl Lewis
Protocol #18-0247, No Longer Enrolling: 3/25/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03864042

A Phase II, Open-Labeled, Multi-Center, Randomized Controlled Trial of Vinblastine +/- Bevacizumab for the Treatment of Chemotherapy-Naive Children with Unresectable or Progressive Low Grade Glioma (LGG)

Principal Investigator: Kathleen Dorris
Protocol #16-2322, No Longer Enrolling: 4/15/2021
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT02840409

A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + TGR-1202 with or without Bendamustine and TGR-1202 alone in Patients with Previously Treated Non-Hodgkin's Lymphoma

Protocol #17-6238, No Longer Enrolling: 10/1/2019
Locations: Greeley Hospital; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital;

More information available at ClinicalTrials.gov: NCT02793583

Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) vs. Radiotherapy with Concurrent Cetuximab in Patients with Locoregionally Advanced Head and Neck Cancer with a Contraindication to Cisplatin

Principal Investigator: ROBYN SWING
Protocol #18-0286, No Longer Enrolling: 8/13/2020
Locations: Greeley Campus; Harmony Campus; Lone Tree Medical Center; Long's Peak Hospital; Longs Peak Hospital; Medical Center of the Rockies; Memorial Hospital Central; Poudre Valley Hospital; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03258554

A Multi-Site Randomized Phase I/II Study of Stereotactic Ablative Body Radiotherapy +/- MEDI 4736 (Durvalumab) for Medically Inoperable Early- Stage Non-Small Cell Lung Cancer

Principal Investigator: ROBYN SWING
Protocol #18-0504, No Longer Enrolling: 5/13/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03148327

Impact of Oral mCRPC Therapies Stewardship Pilot Program for Veterans

Principal Investigator: Caitlin Hutchinson
Protocol #18-0167, No Longer Enrolling: 12/23/2020
Location: Rocky Mountain Regional VA Medical Center;

NRG GU-005:PHASE III IGRT AND SBRT VS IGRT AND HYPOFRACTIONATED IMRT FOR LOCALIZED INTERMEDIATE RISK PROSTATE CANCER

Principal Investigator: ROBYN SWING
Protocol #18-0285, No Longer Enrolling: 10/7/2020
Locations: Lone Tree Medical Center; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03367702

An International, Multicenter, Open-label, Randomized, Phase 3 Study of BLU-285 vs Regorafenib in Patients with Locally Advanced Unresectable or Metastatic Gastrointestinal Stromal Tumor (GIST)

Protocol #18-0269, No Longer Enrolling: 11/8/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03465722

A Phase I Multicenter Study of Immunotherapy in Combination with Chemoradiation in Patients with Advanced Solid Tumors (CLOVER)

Principal Investigator: Jillian Welker
Protocol #18-0541, No Longer Enrolling: 4/2/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03509012

Randomized Phase II Study of Neoadjuvant Nivolumab with and without Urelumab in Cisplatin-Ineligble or Chemotherapy-refusing Patients with Cisplatin-Ineligible Muscle-Invasive Urothelial Carcinoma of the Bladder

A comparison of Neoadjuvant Nivolumab with versus without Urelumab in patients with cisplatin-ineligible bladder cancer

Principal Investigator: Elizabeth Kessler
Protocol #18-0760, No Longer Enrolling: 6/2/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02845323

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF TALAZOPARIB WITH ENZALUTAMIDE IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCER

A comparison of Talazoparib plus enzalutamide vs placebo plus enzalutamide

Principal Investigator: Elizabeth Kessler
Protocol #18-0884, No Longer Enrolling: 4/9/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03395197

RT CHARM: PHASE III RANDOMIZED TRIAL OF HYPOFRACTIONATED POST MASTECTOMY RADIATION WITH BREAST RECONSTRUCTION

Principal Investigator: Chelsea Schaefer
Protocol #18-0627, No Longer Enrolling: 8/17/2021
Locations: Highlands Ranch Hospital; Memorial Hospital Central; Memorial Hospital North; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03414970

A Phase Ib/2 Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of Oleclumab (MEDI9447) with or without Durvalumab in Combination with Chemotherapy in Subjects with Metastatic Pancreatic Ductal Adenocarcinoma

Protocol #18-0871, No Longer Enrolling: 10/23/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03611556

A PHASE 1B/2 STUDY TO EVALUATE SAFETY AND CLINICAL ACTIVITY OF COMBINATIONS OF AVELUMAB, BINIMETINIB AND TALAZOPARIB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC RAS-MUTANT SOLID TUMORS

Principal Investigator: Sheri Neu
Protocol #18-0965, No Longer Enrolling: 4/10/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03637491

ProSTAR: A Phase 1b/2 Study of CPI-1205, a Small Molecule Inhibitor of EZH2, Combined with Enzalutamide or Abiraterone/Prednisone in Patients with Metastatic Castration Resistant Prostate Cancer.

A comparison of enzalutamide with and without CPI1205 in patients with metastatic prostate cancer

Principal Investigator: Daniel Heck
Protocol #18-0990, No Longer Enrolling: 3/7/2020
Locations: Lone Tree Medical Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03480646

Phase I/Ib trial of radiotherapy in combination with Durvalumab (MEDI4736) prior to surgical resection for HPV negative squamous cell carcinoma of the head and neck (HNSCC)

Principal Investigator: Sana Karam
Protocol #18-0606, No Longer Enrolling: 3/3/2021
Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital; Poudre Valley Hospital; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03635164

A Randomized Phase 2 Trial of AM0010 in Combination With Nivolumab vs. Nivolumab Alone as Second-Line Therapy in Subjects With Stage IV / Metastatic Wild Type Non-Small Cell Lung Cancer and Low Tumor Expression of PD-L1

Principal Investigator: Robert Hoyer
Protocol #18-6506, No Longer Enrolling: 12/5/2019
Locations: Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital;

More information available at ClinicalTrials.gov: NCT03382912

A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145/LN-145-S1) for the Treatment of Patients with Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

Principal Investigator: Antonio Jimeno
Protocol #18-1049, No Longer Enrolling: 12/22/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03083873

A Phase 1, Open-Label, Multicenter, Dose-Escalation Study of RMC-4630 Monotherapy in Adult Participants with Relapsed/Refractory Solid Tumors. Protocol v.1.3

Principal Investigator: AMANDA KUPNIEWSKI
Protocol #18-1150, No Longer Enrolling: 11/16/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03634982

An open-label, Phase I study to assess the safety of NKR-2 treatment administration after a non-myeloablative preconditioning chemotherapy in relapse/refractory acute myeloid leukemia or myelodysplastic syndrome patients.

Principal Investigator: Dan Pollyea
Protocol #18-1093, No Longer Enrolling: 8/26/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03466320

Nivolumab with standard of care chemotherapy for the first line treatment of peripheral T cell lymphoma

Principal Investigator: Brad Haverkos
Protocol #18-0708, No Longer Enrolling: 12/18/2020
Locations: City of Hope Cancer Center; Lone Tree Medical Center; Thomas Jefferson University Hospital Cancer Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03586999

Adjuvant Therapy with Pembrolizumab versus Placebo in Resected High Risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study (KEYNOTE 716) Sponsor Protocol No. MK-3475-716

Principal Investigator: Carolyn Dilz
Protocol #18-1199, No Longer Enrolling: 5/4/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03553836

Effect of guided imagery for radiotherapy-related distress: A randomized controlled trial for patients with head and neck cancer

Principal Investigator: Elissa Kolva
Protocol #18-1100, No Longer Enrolling: 11/10/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03662698

A221504 A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PILOT STUDY OF AN ORAL, SELECTIVE PERIPHERAL OPIOID RECEPTOR ANTAGONIST IN ADVANCED NON-SMALL CELL LUNG CANCER

Principal Investigator: Alicia Deschaine
Protocol #18-1203, No Longer Enrolling: 7/28/2020
Locations: Memorial Hospital Central; Memorial Hospital North;

More information available at ClinicalTrials.gov: NCT03087708

Phase 1-2 Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Anti-TIM-3 Monoclonal Antibody BGB-A425 in Combination with Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients with Advanced Solid Tumors

Principal Investigator: Sheri Neu
Protocol #18-1263, No Longer Enrolling: 2/5/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03744468

A Randomized Phase 2 Study of Losartan and Nivolumab in Combination With FOLFIRINOX and SBRT in Localized Pancreatic Cancer

Principal Investigator: Matthew Lee
Protocol #18-1347, No Longer Enrolling: 4/2/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03563248

A Randomized, Open-label, Phase II Clinical Trial of Relatlimab (anti-LAG-3) plus Nivolumab in Combination with Chemotherapy Versus Nivolumab in Combination with Chemotherapy as First-Line Treatment in Patients with Gastric or Gastroesophageal Junction Adenocarcinoma

Protocol #18-1430, No Longer Enrolling: 10/23/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03662659

An Open-label, Single-arm, Phase 1b Study to Evaluate the Safety and Efficacy of Grapiprant (ARY-007) in Combination with Pembrolizumab in Patients with Advanced or Progressive Microsatellite Stable (MSS) Colorectal Cancer (CRC)

Principal Investigator: Alexis Leal
Protocol #18-1431, No Longer Enrolling: 4/16/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03658772

NRG-DT001: A PHASE IB TRIAL OF NEOADJUVANT AMG 232 CONCURRENT WITH PREOPERATIVE RADIOTHERAPY IN WILD-TYPE P53 SOFT TISSUE SARCOMA (STS)

Principal Investigator: ROBYN SWING
Protocol #18-1477, No Longer Enrolling: 3/4/2020
Locations: Greeley Hospital; Harmony Campus; Longs Peak Hospital; Medical Center of the Rockies; Poudre Valley Hospital; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03217266

A PHASE II STUDY OF ISATUXIMAB (SAR650984) (NSC-795145) FOR PATIENTS WITH PREVIOUSLY TREATED AL AMYLOIDOSIS

Protocol #18-1214, No Longer Enrolling: 10/2/2019
Locations: Greeley Hospital; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital;

More information available at ClinicalTrials.gov: NCT03499808

EA2165 A Randomized Phase III Study of Nivolumab after Combined Modality Therapy (CMT) in High Risk Anal Cancer

Principal Investigator: Alexis Leal
Protocol #18-1216, No Longer Enrolling: 8/28/2021
Locations: Greeley Campus; Harmony Campus; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital; Poudre Valley Hospital; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03233711

ATHENA (A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy)

Principal Investigator: Kian Behbakht
Protocol #18-1337, No Longer Enrolling: 2/19/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03522246

A Phase 1a / 1b, First-in-human, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-0903 Administered Daily for 21 Days to Patients with Advanced Solid Tumors

Principal Investigator: Ana Nguyen
Protocol #18-1659, No Longer Enrolling: 6/2/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02729298

A Phase 3, Randomized, Open-label Study of NKTR-214 Combined with Nivolumab Versus Nivolumab in Participants with Previously Untreated Unresectable or Metastatic Melanoma - Sponsor Protocol No. CA045-001

Principal Investigator: Theresa Medina
Protocol #18-1343, No Longer Enrolling: 10/2/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03635983

NRG-GU006: A PHASE II, DOUBLE-BLINDED, PLACEBO-CONTROLLED RANDOMIZED TRIAL OF SALVAGE RADIOTHERAPY WITH OR WITHOUT ENHANCED ANTI-ANDROGEN THERAPY WITH APALUTAMIDE IN RECURRENT PROSTATE CANCER (BALANCE)

Evaluating the addition of apalutamide to radiotherapy for men with recurrent prostate cancer

Principal Investigator: Sherryl Esplana
Protocol #18-1742, No Longer Enrolling: 2/14/2020
Locations: Greeley Hospital; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital; Poudre Valley Hospital; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03371719

An Open-label, Phase 1B Study of NEO-PV-01 + CD40 Agonist Antibody (APX005M) or Ipilimumab with Nivolumab in Patients with Advianced or Metastatic Melanoma - Sponsor Protocol No. NT-003

Principal Investigator: Karl Lewis
Protocol #18-1422, No Longer Enrolling: 12/18/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03597282

Phase 1, two-part (dose escalation, dose expansion), multicenter, non-randomized, open-label, multiple dose, first-in-human study of CA102N monotherapy and of CA102N combined with trifluridine/tipiracil (LONSURF) in subjects with advanced solid tumors

Principal Investigator: Antonio Jimeno
Protocol #18-1721, No Longer Enrolling: 1/27/2021
Locations: Greeley Campus; Highlands Ranch Hospital; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03616574

A phase I, open-label, dose-escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK3368715 in participants with solid tumors and DLBCL

Protocol #18-1741, No Longer Enrolling: 10/1/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03666988

A Phase 2 Study of INCMGA00012 in Participants With Metastatic Merkel Cell Carcinoma

Principal Investigator: Karl Lewis
Protocol #18-1599, No Longer Enrolling: 6/22/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03599713

Square wave testosterone therapy in castration resistant prostate cancer

Feasibility of the administration of transdermal testosterone alternating with enzalutamide and the effects it has in the treatment of prostate cancer

Principal Investigator: Elizabeth Kessler
Protocol #18-0821, No Longer Enrolling: 5/25/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03734653

A211401: REDUCING SURGICAL COMPLICATIONS IN NEWLY DIAGNOSED LUNG CANCER PATIENTS WHO SMOKE CIGARETTES

Protocol #18-1595, No Longer Enrolling: 11/19/2019
Locations: Memorial Hospital Central; Memorial Hospital North;

More information available at ClinicalTrials.gov: NCT02856581

A multicenter study with an open-label Phase Ib part followed by a randomized, placebo-controlled, double-blind, Phase II part to evaluate efficacy, safety, tolerability, and pharmacokinetics of the DNA-PK inhibitor M3814 in combination with capecitabine and radiotherapy in participants with locally advanced rectal cancer

Protocol #18-1869, No Longer Enrolling: 10/1/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03770689

Open Label Phase 2 Study of Tisotumab Vedotin for Patients with Platinum-Resistant Ovarian Cancer with a Safety Run-in of a Dose-Dense Regimen

Principal Investigator: Sara Twombly
Protocol #18-6061, No Longer Enrolling: 5/8/2021
Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies;

More information available at ClinicalTrials.gov: NCT03657043

A PHASE 3, MULTICENTER, RANDOMIZED, OPEN LABEL STUDY TO COMPARE THE EFFICACY AND SAFETY OF BB2121 VERSUS STANDARD REGIMENS IN SUBJECTS WITH RELAPSED AND REFRACTORY MULTIPLE MYELOMA (RRMM) (KarMMa-3)

Principal Investigator: Derek Schatz
Protocol #18-1983, No Longer Enrolling: 3/21/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03651128

A Phase II, Open Label, Randomised, Multi-centre Study to Assess the Safety and Efficacy of Agents Targeting DNA Damage Repair in Combination with Olaparib versus Olaparib Monotherapy in the Treatment of Metastatic Triple Negative Breast Cancer Patients Stratified by Alterations in Homologous Recombinant Repair (HRR)-related Genes

Principal Investigator: Anosheh Afghahi
Protocol #18-1933, No Longer Enrolling: 11/25/2020
Locations: Lone Tree Medical Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03330847

A RANDOMIZED PHASE 3, OPEN-LABEL TRIAL OF SIPULEUCEL-T ADMINISTERED TO PATIENTS ON ACTIVE SURVEILLANCE FOR NEWLY DIAGNOSED PROSTATE CANCER

A comparison of Provenge versus active surveillance in low risk prostate cancer patients.

Protocol #18-1980, No Longer Enrolling: 10/5/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03686683

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Nirogacestat Versus Placebo in Adult Patients with Progressing Desmoid Tumors/Aggressive Fibromatosis (DT/AF).

Principal Investigator: Flora Martinez
Protocol #18-1858, No Longer Enrolling: 7/10/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03785964

A Phase 3, Interventional, Randomized, Multicenter, Open-Label Study of DCC-2618 vs Sunitinib in Patients with Advanced Gastrointestinal Stromal Tumors after Treatment with Imatinib

Principal Investigator: Anthony Elias
Protocol #18-1856, No Longer Enrolling: 12/1/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03673501

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Cabozantinib (XL184) in Subjects with Radioiodine-Refractory Differentiated Thyroid Cancer Who Have Progressed after Prior VEGFR-Targeted Therapy

Principal Investigator: Daniel Bowles
Protocol #18-1919, No Longer Enrolling: 1/8/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03690388

An Open-label, Phase 1b/2 Study of Acalabrutinib Alone or in Combination Therapy in Subjects with B-cell Non-Hodgkin Lymphoma

Principal Investigator: Alicia Deschaine
Protocol #18-6510, No Longer Enrolling: 9/29/2021
Locations: Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital;

More information available at ClinicalTrials.gov: NCT02180711

Phase I trial of indoximod in combination with temozolomide-based therapy for children with progressive primary brain tumors (NLG2105)

Principal Investigator: Kathleen Dorris
Protocol #18-2309, No Longer Enrolling: 9/30/2020
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT02502708

"A Phase 1 Open-Label Study to Evaluate the Safety and Antitumor Activity of oncastuximab Tesirine and Durvalumab in Patients with advanced Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, or Follicular Lymphoma"

Principal Investigator: Angie Valdez
Protocol #18-6118, No Longer Enrolling: 11/26/2019
Locations: Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital;

More information available at ClinicalTrials.gov: NCT03685344

A PHASE 1 STUDY OF OKI-179 AS A SINGLE AGENT IN PATIENTS WITH ADVANCED SOLID TUMORS

Principal Investigator: Chris Lieu
Protocol #18-1816, No Longer Enrolling: 10/2/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03931681

A Phase 3 Randomized, Placebo-controlled Trial to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) and Lenvatinib (E7080/MK-7902) Versus Pembrolizumab Alone as First-line Intervention in Participants with Advanced Melanoma (LEAP-003)

Principal Investigator: Karl Lewis
Protocol #18-2198, No Longer Enrolling: 5/6/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03820986

Phase II, open-label, single arm, multicenter study of encorafenib, binimetinib plus cetuximab in subjects with previously untreated BRAF V600E -mutant Metastatic Colorectal Cancer

Principal Investigator: Chris Lieu
Protocol #18-2293, No Longer Enrolling: 1/31/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03693170

A Phase 1b/2 Study of FT-2102 in Patients with Advanced Solid Tumors and Gliomas with an IDH1 Mutation

Principal Investigator: Denise M. Damek
Protocol #18-2219, No Longer Enrolling: 8/28/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03684811

A PHASE 2 STUDY OF AZD1775, A WEE1 INHIBITOR, IN PATIENTS WITH CCNE1 AMPLIFICATION

Principal Investigator: Anthony Elias
Protocol #18-2334, No Longer Enrolling: 7/11/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03253679

A Phase 2 Study of M6620 in Combination with Carboplatin compared with Docetaxel in Combination with Carboplatin in Metastatic Castration-Resistant Prostate Cancer

A comparison of M6620 + Carboplatin versus Docetaxel + Carboplatin in metastatic castrate-resistant prostate cancer

Principal Investigator: Elizabeth Kessler
Protocol #18-2398, No Longer Enrolling: 8/7/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03517969

A Phase 2, multicenter, open-label, 2-cohort study of trastuzumab deruxtecan (DS-8201a), an anti-HER2 antibody drug conjugate (ADC), for HER2-over-expressing or -mutated, unresectable and/or metastatic non-small cell lung cancer (NSCLC)

Principal Investigator: ANDREA MARTINSEN
Protocol #18-2488, No Longer Enrolling: 12/16/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03505710

A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects with Selected Solid Tumors (LEAP-005)

Principal Investigator: Bradley Corr
Protocol #18-2466, No Longer Enrolling: 4/10/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03797326

A Phase 2, Open-label, Multicenter, Randomized, Multidrug Platform Study of Durvalumab Alone or in Combination with Novel Agents in Subjects with Locally Advanced, Unresectable, Stage III Non-small Cell Lung Cancer (COAST)

Principal Investigator: Nicole Conti
Protocol #18-2487, No Longer Enrolling: 7/1/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03822351

A Stepped Care Intervention to Reduce Disparities in Mental Health Services among Underserved Lung and Head-and-Neck Cancer Patients and their Caregivers.

Principal Investigator: David Raben
Protocol #16-2621, No Longer Enrolling: 1/6/2021
Locations: Denver Health Medical Center; National Jewish Health; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03016403

Phase I Study of Dual Immune Checkpoint Blockade (Anti-PD-L1 (Durvalumab) (MEDI4736) and Anti-CTLA4 (Tremelimumab) Plus Yttrium-90 (Y-90) Radioembolization & Stereotactic Body Radiation Therapy (SBRT) in Refractory Metastatic MSS (Microsatellite Stable) Colorectal Cancer with Liver Metastases

Protocol #18-0710, No Longer Enrolling: 10/1/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03802747

A phase III, multicenter, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, early breast cancer (New Adjuvant TriAl with Ribociclib [LEE011]:NATALEE).

Principal Investigator: Elena Shagisultanova
Protocol #18-2357, No Longer Enrolling: 4/9/2020
Locations: Lone Tree Medical Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03701334

PHASE II, DOUBLE-BLIND, RANDOMIZED TRIAL OF AVOVA-1 (AUTOLOGOUS DENDRITIC CELLS LOADED WITH AUTOLOGOUS TUMOR ASSOCIATED ANTIGENS) VS. AUTOLOGOUS PERIPHERAL BLOOD MONONUCLEAR CELLS (MC) IN PATIENTS WITH STAGE III OR IV EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CARCINOMA AFTER PRIMARY THERAPY

Principal Investigator: Bradley Corr
Protocol #18-2569, No Longer Enrolling: 6/10/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02033616

A Phase 2 Study to Evaluate the Clinical Activity of Tarloxotinib in Patients with Non-Small Cell Lung Cancer that Harbors Either an EGFR Exon 20 Insertion or a HER2-Activating Mutation and Other Advanced Solid Tumors with NRG1/ERBB Family Gene Fusions

Principal Investigator: Gianna Morales
Protocol #19-0011, No Longer Enrolling: 1/30/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03805841

A randomized, multicenter, parallel-group, Phase III study to compare the efficacy of arfolitixorin versus leucovorin in combination with 5-fluorouracil, oxaliplatin, and bevacizumab in patients with advanced colorectal cancer

Principal Investigator: Alicia Deschaine
Protocol #18-6515, No Longer Enrolling: 9/14/2021
Location: Memorial Hospital Central;

More information available at ClinicalTrials.gov: NCT03750786

AREN1721: A Randomized Phase 2 Trial of Axitinib/Nivolumab Combination Therapy vs. Single Agent Axitinib or Nivolumab for the Treatment of TFE/Translocation Renal Cell Carcinoma (tRCC) Across All Age Groups

A comparison of Axitinib plus Nivolumab vs Axitinib vs Nivolumab in treatment of unresectable kidney cancer

Principal Investigator: Daniel Heck
Protocol #19-0048, No Longer Enrolling: 3/26/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03595124

A PHASE III, DOUBLE-BLINDED, MULTICENTER, RANDOMIZED STUDY EVALUATING THE EFFICACY AND SAFETY OF NEOADJUVANT TREATMENT WITH ATEZOLIZUMAB OR PLACEBO IN COMBINATION WITH PLATINUM-BASED CHEMOTHERAPY IN PATIENTS WITH RESECTABLE STAGE II, IIIA, OR SELECT IIIB NON SMALL CELL LUNG CANCER

Principal Investigator: Cole Sprague
Protocol #19-0127, No Longer Enrolling: 7/27/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03456063

A PHASE 1 STUDY TO EVALUATE THE EFFECT OF HEPATIC IMPAIRMENT ON THE PHARMACOKINETICS AND SAFETY OF LORLATINIB IN ADVANCED CANCER PATIENTS

Principal Investigator: CINDY O'BRYANT
Protocol #19-0233, No Longer Enrolling: 4/10/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03726333

An Open-Label, Multicenter, Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination with Paclitaxel to Assess Safety, Tolerability, and Pharmacokinetics in Patients with Advanced or Metastatic Solid Tumors

Principal Investigator: Jennifer Diamond
Protocol #19-0207, No Longer Enrolling: 11/16/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03601897

A PHASE I, MULTICENTER, OPEN-LABEL PREOPERATIVE, SHORT-TERM WINDOW STUDY OF GDC-9545 IN POSTMENOPAUSAL WOMEN WITH STAGE I-III OPERABLE, ESTROGEN RECEPTOR-POSITIVE BREAST CANCER

A PHASE I, MULTICENTER, OPEN-LABEL PREOPERATIVE, SHORT-TERM WINDOW STUDY OF GDC-9545 IN POSTMENOPAUSAL WOMEN WITH STAGE IIII OPERABLE, ESTROGEN RECEPTORPOSITIVE BREAST CANCER

Principal Investigator: Gwendolyn Wade
Protocol #19-0206, No Longer Enrolling: 6/9/2021
Locations: Lone Tree Medical Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03916744

Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in subjects with Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer (MBC) who have failed at least two prior chemotherapy regimens

Principal Investigator: Jennifer Diamond
Protocol #19-0326, No Longer Enrolling: 3/25/2020
Locations: Highlands Ranch Hospital; Lone Tree Medical Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03901339

A Phase 1, open label, first-in-human study of TR1801-ADC, an antibody drug conjugate (ADC), in patients with select solid tumors expressing c-Met

Principal Investigator: Meghan Ayers
Protocol #19-0232, No Longer Enrolling: 10/9/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03859752

A Phase 2, Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-Mutant Melanoma Brain Metastasis

Principal Investigator: Danielle Gilbert
Protocol #19-0161, No Longer Enrolling: 4/3/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03911869

Elacestrant Monotherapy vs. Standard of Care for the Treatment of Patients with ER+/HER2- Advanced Breast Cancer Following CDK4/6 Inhibitor Therapy: A Phase 3 Randomized, Open-Label, Active-Controlled, Multicenter Trial

Principal Investigator: Diana Medgyesy
Protocol #19-6041, No Longer Enrolling: 9/9/2020
Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital;

More information available at ClinicalTrials.gov: NCT03778931

CCTG MA.39 TAILOR RT: A RANDOMIZED TRIAL OF REGIONAL RADIOTHERAPY IN BIOMARKER LOW RISK NODE POSITIVE BREAST CANCER

Principal Investigator: Rachel Rabinovitch
Protocol #19-0476, No Longer Enrolling: 8/11/2021
Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03488693

A Phase 3, Randomized, Double-blind Study of Pembrolizumab (MK-3475) Plus Docetaxel Plus Prednisone versus Placebo Plus Docetaxel Plus Prednisone in Participants with Chemotherapy-naive Metastatic Castration-Resistant Prostate Cancer (mCRPC) who have Progressed on a Next Generation Hormonal Agent (NHA) (KEYNOTE- 921)

A comparison of Pembrolizumab plus Docetaxel versus placebo plus Docetaxel in patients with chemo-naive, metastatic prostate cancer.

Principal Investigator: Jacquelyn Schrack
Protocol #19-0473, No Longer Enrolling: 5/21/2021
Locations: Highlands Ranch Hospital; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03834506

A Phase 3 Randomized, Open-Label, Study of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for First-line Treatment of Advanced or Recurrent Endometrial Carcinoma (LEAP-001)

Principal Investigator: Bradley Corr
Protocol #19-0507, No Longer Enrolling: 6/17/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03884101

A randomized phase II study of anti-PD-1 and limited metastatic site radiation therapy versus anti-PD-1 alone for patients with microsatellite instability-high (MSI-H) and mismatch repair deficient (dMMR) metastatic solid tumors

Principal Investigator: Christine Fisher
Protocol #19-0556, No Longer Enrolling: 11/18/2021
Locations: Lone Tree Medical Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04001101

Treatment Patterns, Mechanisms of Resistance and Outcomes among patients with EGFR, ALK and ROS1 Translocated Non-Small Cell Lung Cancer: An ATOMIC Consortium Analysis

Principal Investigator: Nicole Conti
Protocol #19-0702, No Longer Enrolling: 12/21/2019
Location: University of Colorado Hospital;

S1600 A Randomized Phase III Double-Blind Clinical Trial Evaluating the Effect of Immune-Enhancing Nutrition on Radical Cystectomy Outcomes

Comparison of drink supplements in evaluation of post-operative Bladder cancer patients

Protocol #19-0818, No Longer Enrolling: 10/8/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03757949

EA8171: Multiparametric MRI (mpMRI) for Preoperative Staging and Treatment Planning for Newly-Diagnosed Prostate Cancer

Multiparametric MRI in Evaluating Cancer Stage and Helping Treatment Planning in Patients With Prostate cancer

Protocol #19-0819, No Longer Enrolling: 10/17/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03697148

NRG GY017: Anti PD-L1 (Atezolizumab) as an Immune Primer and Concurrently with Extended Field Chemoradiotherapy for Node Positive Locally Advanced Cervical Cancer

Principal Investigator: Anna Sweetser
Protocol #19-1151, No Longer Enrolling: 6/12/2020
Locations: Lone Tree Medical Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03738228

EA5163/S1709 INSIGNA: A Randomized, Phase III Study of Firstline Immunotherapy alone or in Combination with Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) with Immunobiomarker SIGNature-driven Analysis

Principal Investigator: Jillian Murphy
Protocol #19-1121, No Longer Enrolling: 10/27/2020
Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Medical Center of the Rockies; Poudre Valley Hospital; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03793179

S1900A, A PHASE II STUDY OF RUCAPARIB IN PATIENTS WITH GENOMIC LOH HIGH AND/OR DELETERIOUS BRCA1/2 MUTATION STAGE IV OR RECURRENT NON-SMALL CELL LUNG CANCER (Lung-MAP SUB-STUDY)

Principal Investigator: Gianna Morales
Protocol #19-1317, No Longer Enrolling: 7/21/2020
Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03845296

S1800A, A PHASE II RANDOMIZED STUDY OF RAMUCIRUMAB PLUS MK3475 (PEMBROLIZUMAB) VERSUS STANDARD OF CARE FOR PATIENTS PREVIOUSLY TREATED WITH IMMUNOTHERAPY FOR STAGE IV OR RECURRENT NON-SMALL CELL LUNG CANCER (LUNG-MAP NON-MATCHED SUB-STUDY)

Principal Investigator: Gianna Morales
Protocol #19-1318, No Longer Enrolling: 11/21/2020
Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03971474

Assessing patient preferences and a clinical tool for evaluating for sexual function in adolescent and young adult survivors of childhood cancer

Principal Investigator: Jenna Sopfe
Protocol #19-1111, No Longer Enrolling: 12/4/2020
Locations: Childrens Hospital Colorado; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04066218

10100: A Randomized, Phase 2 Trial to Evaluate the Safety and Efficacy of Eribulin Mesylate in Combination with Atezolizumab Compared to Atezolizumab Alone in Subjects with Locally Advanced or Metastatic Transitional Cell Urothelial Cancer Where Platinum-Based Treatment is Not an Option

Principal Investigator: Elaine Lam
Protocol #19-1394, No Longer Enrolling: 3/17/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03237780

This is our 15.4 Health Affairs testing protocol

Principal Investigator: AMANDA CHILDS
Protocol #X19-9999, No Longer Enrolling: 6/2/2020
Locations: Department Specific Free Standing Clinic; Highlands Ranch Hospital; University of Colorado Hospital;

A Phase 2, Randomized, Open-label, 3-arm Study of Relacorilant in Combination with Nab-Paclitaxel for Patients with Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Principal Investigator: Bradley Corr
Protocol #19-0591, No Longer Enrolling: 7/28/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03776812

ELACESTRANT MONOTHERAPY VS. STANDARD OF CARE FOR THE TREATMENT OF PATIENTS WITH ER+/HER2- ADVANCED BREAST CANCER FOLLOWING CDK4/6 INHIBITOR THERAPY: A PHASE 3 RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER TRIAL (EMERALD)

Principal Investigator: Leah Adams
Protocol #19-0327, No Longer Enrolling: 9/26/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03778931

Analyzing differences in treatment regimens and outcomes in elderly breast, lung, and colorectal cancer patients using the SEER-Medicare database

Principal Investigator: Cathy Bradley
Protocol #18-0156, No Longer Enrolling: 11/28/2019
;

Serum Acetaminophen-Cystein (APAP-CYS) Adduct Concentrations in Subjects Expected to Develop Aminotransferase Elevations with Liver-Directed Therapy Intended to Treat Hepatic Tumors

This study aims to describe protein adduct (an experimental biomarker of acetaminophen exposure) concentrations in patients taking therapeutic doses of acetaminophen who develop a liver injury from a cause other than acetaminophen.To describe serum acetaminophen-cysteine adduct (an experimental biomarker of acetaminophen exposure) concentrations following hepatic embolization in patients taking therapeutic doses of acetaminophen three days before the procedure

Principal Investigator: Diana Flores
Protocol #16-0031, No Longer Enrolling: 9/3/2021
Locations: CTRC Inpatient; Denver Health and Hospital Authority; Outpatient CTRC; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02911961

A Phase I/II Open-label, Multi-center Study of the Safety and Efficacy of IMCnyeso, an HLA- A0201-Restricted, NY-ESO-1- and LAGE-1A-specific Soluble T Cell Receptor and Anti-CD3 Bispecific Molecule, as a Single Agent in HLA-A0201 Positive Patients with Advanced NY-ESO-1 and/or LAGE-1A Positive Cancer.

Principal Investigator: Breelyn Wilky
Protocol #18-2404, No Longer Enrolling: 3/27/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03515551

Phase 1 Dose Escalation and Expansion Cohort Trial of Carboplatin and Gemcitabine with or without M6620 (VX-970) in First or Second Recurrence Platinum-Sensitive Epithelial Ovarian, Peritoneal, and Fallopian Tube Cancer

Principal Investigator: Bradley Corr
Protocol #19-0457, No Longer Enrolling: 9/2/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02627443

A Phase II Study of the PARP Inhibitor Olaparib in Combination with the DNA Damaging Agent Temozolomide for the Treatment of Advanced Uterine Leiomyosarcoma

Principal Investigator: Bradley Corr
Protocol #19-2018, No Longer Enrolling: 2/22/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03880019

NRG-LU003: A BIOMARKER-DRIVEN PROTOCOL FOR PREVIOUSLY TREATED ALK-POSITIVE NON-SQUAMOUS NSCLC PATIENTS: THE NCI-NRG ALK PROTOCOL

Principal Investigator: ANDREA MARTINSEN
Protocol #19-1146, No Longer Enrolling: 4/2/2021
Locations: Memorial Hospital Central; Memorial Hospital North; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03737994

An Open-Label Dose Escalation Trial to Evaluate Dose Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD), Safety, and Tolerability of Microneedle Arrays containing Doxorubicin (D-MNA) in Participants with Basal Cell Carcinoma (BCC)

The participant will be treated with microneedle arrays containing doxorubicin (D-MNA) or microneedle arrays containing placebo. The D-MNA or MNA-placebo is applied to the BCC lesion and secured to the skin with a self-adhesive bandage. The D-MNA is removed from the skin after 30 minutes. Each participant will receive three (3) weekly applications of the D-MNA unless a dose limiting toxicity (DLT) requires skipping or postponement of an application. The investigational product is chemotherapeutic agent doxorubicin (25 ug, 50 ug, 100 ug, or 200 ug) delivered to specific skin strata by a novel delivery system, MNA or placebo delivered to specific skin strata by MNA.

Principal Investigator: Cheryl Armstrong
Protocol #19-0035, No Longer Enrolling: 12/18/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03646188

A Phase 2 Open Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects with Metastatic Solid Tumors

Principal Investigator: Emily Drees
Protocol #19-0946, No Longer Enrolling: 3/21/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03964727

A Phase 3, Randomized, Double-blind Study of Adjuvant Nivolumab versus Placebo for Participants with Hepatocellular Carcinoma Who Are at High Risk of Recurrence after Curative Hepatic Resection or Ablation

Principal Investigator: Meredith Waring
Protocol #19-0820, No Longer Enrolling: 1/6/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03383458

A Phase 1/2, First-in-Human, Open-label, Dose Escalation Study of GB1275 Monotherapy and in Combination with an Anti-PD-1 Antibody in Patients with Specified Advanced Solid Tumors or in Combination with Standard of Care in Patients with Metastatic Pancreatic Adenocarcinoma, Followed by Basket Expansion of GB1275 with Standard of Care or in Combination with an Anti-PD-1 Antibody in Patients with Specified Metastatic Solid Tumors

Principal Investigator: CHALAUNDA SCOTT
Protocol #19-1302, No Longer Enrolling: 7/1/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04060342

A Randomized, Single-Blinded, Phase 3 Study of Second- or Third-Line Chemotherapy with Docetaxel + Plinabulin Compared to Docetaxel + Placebo in Patients with Advanced Non-Small Cell Lung Cancer with at Least One Measurable Lung Lesion (DUBLIN-3)

Principal Investigator: Caralyn Henderson
Protocol #15-6056, No Longer Enrolling: 12/25/2019
Location: Memorial Hospital Central;

Randomized Phase II Trial of Topotecan plus M6620 (VX-970) vs. Topotecan alone in Patients with Relapsed Small-Cell Lung Cancer

Principal Investigator: Jose Pacheco
Protocol #19-2129, No Longer Enrolling: 1/29/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03896503

SGNTUC-016: Randomized, double-blind, phase 3 study of tucatinib or placebo in combination with ado-trastuzumab emtansine (T-DM1) for subjects with unresectable locally-advanced or metastatic Her2+ breast cancer

Principal Investigator: Diana Medgyesy
Protocol #19-6076, No Longer Enrolling: 11/17/2021
Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital;

More information available at ClinicalTrials.gov: NCT03975647

A PHASE 3B, MULTICENTER, SINGLE-ARM, OPENLABEL EFFICACY AND SAFETY STUDY OF FEDRATINIB IN SUBJECTS WITH DIPSSINTERMEDIATE OR HIGH-RISK PRIMARY MYELOFIBROSIS, POST-POLYCYTHEMIA VERA MYELOFIBROSIS, OR POST-ESSENTIAL THROMBOCYTHEMIA MYELOFIBROSIS AND PREVIOUSLY TREATED WITH RUXOLITINIB

Principal Investigator: Brandon McMahon
Protocol #19-0562, No Longer Enrolling: 1/22/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03755518

A Randomized, Open-Label, Phase 1-2 Study of ASTX727 Low Dose (ASTX727 LD) Extended Schedule in Subjects with Lower Risk (IPSS Low or Intermediate-1) Myelodysplastic Syndromes (MDS)

Principal Investigator: Dan Pollyea
Protocol #18-0818, No Longer Enrolling: 3/21/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03502668

Improving physical activity maintenance following an exercise program for cancer survivors

Principal Investigator: Heather Leach
Protocol #19-0323, No Longer Enrolling: 10/13/2020
Locations: Anschutz Health and Wellness; UCD Anschutz Health & Wellness Center;

More information available at ClinicalTrials.gov: NCT03976193

A Multicenter, Open-Label, Non-Randomised First in Human Study of NG-350A in Patients with Metastatic or Advanced Epithelial Tumours (FORTITUDE)

Principal Investigator: Aaron Parsons
Protocol #19-1147, No Longer Enrolling: 8/26/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03852511

A031704: PD-Inhibitor (Nivolumab) and Ipilimumab Followed by Nivolumab vs. VEGF TKI Cabozantinib With Nivolumab: A Phase III Trial in Metastatic Untreated Renal Cell Cancer [PDIGREE]

Principal Investigator: Elaine Lam
Protocol #19-1913, No Longer Enrolling: 3/10/2021
Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03793166

AINV18P1: A Phase I Study of Palbociclib (IND# 141416), a CDK4/6 Inhibitor, in Combination with Chemotherapy in Children with Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL)

Principal Investigator: KELLY MALONEY
Protocol #19-0549, No Longer Enrolling: 5/25/2021
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT03792256

Patient characteristics, treatment patterns and outcomes in patients with advanced or metastatic Non-Small Cell Lung Cancer with MET alterations - a multi-country chart review

Principal Investigator: Joshua Saginaw
Protocol #19-1346, No Longer Enrolling: 12/21/2019
Location: University of Colorado Hospital;

A Phase 3, Randomized, Double-blind, Active Comparator-controlled, Multicenter Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Recipients of Allogeneic Hematopoietic Stem Cell Transplant (PNEU-STEM)

Principal Investigator: Kayla Pacheco
Protocol #19-0536, No Longer Enrolling: 9/30/2020
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT03565900

A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Olaparib Alone or in Combination With Bevacizumab Compared to Bevacizumab With 5-FU in Participants with Unresectable or Metastatic Colorectal Cancer who Have not Progressed Following First-line Induction of FOLFOX With Bevacizumab (LYNK-003)

Principal Investigator: Alicia Deschaine
Protocol #19-6513, No Longer Enrolling: 11/2/2021
Locations: Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital;

More information available at ClinicalTrials.gov: NCT04456699

A Multicenter, Double Blind, Randomized, Controlled Study of M7824 with Concurrent Chemoradiation Followed by M7824 versus Concurrent Chemoradiation Plus Placebo Followed by Durvalumab in Participants with Unresectable Stage III Non-small Cell Lung Cancer

Principal Investigator: Alicia Deschaine
Protocol #19-6066, No Longer Enrolling: 7/25/2020
Locations: Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital;

More information available at ClinicalTrials.gov: NCT03840902

A Single Cohort Phase 4 Trial Investigating the Impact of G-CSF Primary Prophylaxis for Advanced Stage Hodgkin Lymphoma Patients Treated with A+AVD

Principal Investigator: Sara Twombly
Protocol #19-6060, No Longer Enrolling: 11/20/2021
Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital;

More information available at ClinicalTrials.gov: NCT03646123

NRG-GY018: A Phase III Randomized, Placebo-Controlled Study of Pembrolizumab (MK-3475, NSC #776864) in Addition to Paclitaxel and Carboplatin for Measurable Stage III or IVA, Stage IVB or Recurrent Endometrial Cancer

Principal Investigator: Angie Valdez
Protocol #19-2828, No Longer Enrolling: 4/8/2020
Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital;

More information available at ClinicalTrials.gov: NCT03914612

COG ACCL10P1 - Computerized Cognitive Training for Pediatric Brain Tumor Patients: A Pilot Study

Principal Investigator: Kathleen Dorris
Protocol #18-2000, No Longer Enrolling: 12/2/2020
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT01503086

COG ANHL1522 - A Pilot Study of Rituximab (RTX) and Third Party Latent Membrane Protein (LMP)-specific Cytotoxic T-Lymphocytes (LMP-TC, IND # 17068) in Pediatric Solid Organ Recipients (SOT) with EBV-Positive CD20-Positive Post-Transplant Lymphoproliferative Disease (PTLD)

Principal Investigator: KELLY MALONEY
Protocol #18-0198, No Longer Enrolling: 12/22/2020
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT02900976

An Open-Label, Multicenter, First-in-Human, Dose-Escalation, Phase 1 Study of INBRX-105 and INBRX-105 in Combination with Pembrolizumab in Patients with Locally Advanced or Metastatic Solid Tumors

Principal Investigator: Ana Nguyen
Protocol #19-1145, No Longer Enrolling: 8/24/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03809624

A PHASE 2, OPEN-LABEL, MULTI-CENTER STUDY OF AL101 IN PATIENTS WITH ADENOID CYSTIC CARCINOMA (ACC) BEARING ACTIVATING NOTCH MUTATIONS

Principal Investigator: Aubrey Dedin
Protocol #19-2255, No Longer Enrolling: 4/10/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03691207

ACNS1721 - A Phase 2 Study of Veliparib (ABT-888, IND #139199) and Local Irradiation, Followed by Maintenance Veliparib and Temozolomide, in Patients with Newly Diagnosed High-Grade Glioma (HGG) without H3 K27M or BRAFV600E Mutations

Principal Investigator: Barb Shepperd
Protocol #19-1633, No Longer Enrolling: 11/27/2021
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT03581292

The PISCES Study: A Multicenter Phase 2, Open-Label Study of Intratumoral Tavokinogene Telseplasmid (tavo, pIL-12) plus electroporation in Combination with Intravenous Pembrolizumab in Patients with Stage III/IV Melanoma who are Progressing on either Pembrolizumab or Nivolumab Treatment

Principal Investigator: Karl Lewis
Protocol #19-1297, No Longer Enrolling: 11/14/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03132675

An Open label, Phase I/II study to evaluate the safety and efficacy of Tenalisib (RP6530), a novel PI3K dual inhibitor given in combination with a histone deacetylase (HDAC) inhibitor, Romidepsin in adult patients with relapsed/refractory T-cell Lymphoma

Principal Investigator: Brad Haverkos
Protocol #19-1431, No Longer Enrolling: 8/20/2020
Locations: Lone Tree Medical Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03770000

An Investigator-Sponsored, Phase 1/2 trial of the oral XPO1 inhibitor selinexor (KPT-330) in combination with docetaxel for previously treated, advanced KRAS mutant non-small cell lung cancer (NSCLC)

Principal Investigator: ANDREA MARTINSEN
Protocol #18-0554, No Longer Enrolling: 11/19/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03095612

Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, or Other Advanced Solid Tumors: A Phase 1b/2 Study of Cavrotolimod Combined with Pembrolizumab or Cemiplimab

Principal Investigator: MATTHEW SKOCH
Protocol #19-1074, No Longer Enrolling: 9/9/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03684785

ADVL1712: A Feasibility Trial of MLN4924 (Pevonedistat, TAK 924, IND#142772) Given in Combination with Azacitidine, Fludarabine, and Cytarabine, in Children, Adolescents, and Young Adults with Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Principal Investigator: Ashley Mettetal
Protocol #19-2163, No Longer Enrolling: 5/19/2021
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT03813147

Phase 1b Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Repeated Doses of DB-020 in Patients Receiving Cisplatin

Principal Investigator: Elaine Lam
Protocol #19-2560, No Longer Enrolling: 9/4/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04262336

S1826: A PHASE III, RANDOMIZED STUDY OF NIVOLUMAB (OPDIVO) PLUS AVD OR BRENTUXIMAB VEDOTIN (ADCETRIS) PLUS AVD IN PATIENTS (AGE greater than or equal to 12 YEARS) WITH NEWLY DIAGNOSED ADVANCED STAGE CLASSICAL HODGKIN LYMPHOMA

Principal Investigator: Derek Schatz
Protocol #19-2724, No Longer Enrolling: 3/24/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03907488

A Phase 1/2 First-in-human Study of the Safety and Efficacy of IMC-C103C as a Single Agent and in Combination with Atezolizumab in HLA-A 0201-positive Patients with Advanced MAGE-A4-positive Cancer

Principal Investigator: Angelina Delabbio
Protocol #19-2311, No Longer Enrolling: 11/16/2021
Locations: Outpatient CTRC; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03973333

NRG-HN005: A Randomized Phase II/III Trial of De-Intensified Radiation Therapy for Patients with Early-Stage, P16-Positive, Non-Smoking Associated Oropharyngeal Cancer

Principal Investigator: Sana Karam
Protocol #19-2326, No Longer Enrolling: 12/4/2020
Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03952585

A Phase 1b/3 Global, Randomized, Double-blind, Placebo-Controlled Trial of Tazemetostat in Combination With Doxorubicin as Frontline Therapy for Advanced Epithelioid Sarcoma

Principal Investigator: Anthony Elias
Protocol #19-2564, No Longer Enrolling: 4/7/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04204941

MRI for Cardiotoxicity in Kids (MOCK)

Principal Investigator: Emily Palmeri
Protocol #19-3023, No Longer Enrolling: 1/7/2021
Locations: Childrens Hospital Colorado; University of Colorado Hospital;

A Phase I/II, Open-Label, Multicenter Study to Assess the Safety,Tolerability, Pharmacokinetics and Anti-tumor Efficacy of DZD9008 in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with EGFR or HER2 mutation

Principal Investigator: Gianna Morales
Protocol #19-2390, No Longer Enrolling: 2/4/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03974022

A Phase III, Randomized, Open-label Study to Evaluate Pembrolizumab as Neoadjuvant Therapy and in Combination With Standard of Care as Adjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC)

Principal Investigator: Antonio Jimeno
Protocol #17-1756, No Longer Enrolling: 2/12/2021
Locations: Highlands Ranch Hospital; Lone Tree Medical Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03765918

A Phase 1/2 Study of REGN5093 in Patients with MET-Altered Advanced Non-Small Cell Lung Cancer

Principal Investigator: Joshua Saginaw
Protocol #19-1759, No Longer Enrolling: 8/12/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04077099

S1900B, A Phase II Study of Selpercatinib (LOXO-292) in Patients with RET Fusion-Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP Sub-Study)

Principal Investigator: Gianna Morales
Protocol #20-0563, No Longer Enrolling: 5/5/2021
Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04268550

A Randomized, Double-Blind, Phase 3 Study to Evaluate the Activity of Momelotinib (MMB) versus Danazol (DAN) in Symptomatic, Anemic Subjects with Primary Myelofibrosis (PMF), Post-Polycythemia Vera (PV) Myelofibrosis, or Post Essential Thrombocythemia (ET) Myelofibrosis who were Previously Treated with JAK Inhibitor Therapy

To determine the efficacy of MMB versus DAN assessed by improvement in Myelofibrosis Symptom Assessment Form subjects with Primary Myelofibrosis, post-Polycythemia Vera myelofibrosis , or Post Essential Thrombocythemia Myelofibrosis who were previously treated with approved JAK inhibitor therapy.

Principal Investigator: Brandon McMahon
Protocol #19-2520, No Longer Enrolling: 5/19/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04173494

S1900C, A Phase II Study of Talazoparib Plus Avelumab in Patients with Stage IV or Recurrent Non-Squamous Non-Small Cell Lung Cancer Bearing Pathogenic STK11 Genomic Alterations (LUNG-MAP Sub-Study)

Principal Investigator: Gianna Morales
Protocol #20-0564, No Longer Enrolling: 11/21/2020
Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04173507

A Phase 1b Dose-Finding Study of ARO-HIF2 in Patients with Advanced Clear Cell Renal Cell Carcinoma

Principal Investigator: Elaine Lam
Protocol #20-0357, No Longer Enrolling: 10/21/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04169711

A Phase I, Multi-Center, Open-Label, Treatment Duration Increment, Expansion, Safety, and Pharmacodynamic Study of CX-4945 Administered Orally Twice Daily to Patients with Advanced Basal Cell Carcinoma

Principal Investigator: Danielle Gilbert
Protocol #19-1711, No Longer Enrolling: 1/20/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03897036

A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Plus ADT Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (KEYNOTE-991)

Principal Investigator: Elizabeth Kessler
Protocol #19-2999, No Longer Enrolling: 7/8/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04191096

An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Itacitinib in Combination With Corticosteroids for the Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Pediatric Subjects

Principal Investigator: AMY KEATING
Protocol #18-1990, No Longer Enrolling: 10/3/2020
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT03497273

A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy with Nivolumab versus Placebo after Complete Resection of Stage IIB/C Melanoma (CheckMate 76K)

Principal Investigator: Kathy Prinz
Protocol #19-1581, No Longer Enrolling: 8/24/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04099251

A PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ATEZOLIZUMAB GIVEN IN COMBINATION WITH CABOZANTINIB VERSUS CABOZANTINIB ALONE IN PATIENTS WITH INOPERABLE, LOCALLY ADVANCED, OR METASTATIC RENAL CELL CARCINOMA WHO EXPERIENCED RADIOGRAPHIC TUMOR PROGRESSION DURING OR AFTER IMMUNE CHECKPOINT INHIBITOR TREATMENT

Principal Investigator: Elaine Lam
Protocol #20-0881, No Longer Enrolling: 12/1/2021
Locations: Highlands Ranch Hospital; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04338269

Patient and caregiver perspectives in bladder cancer diagnosis and treatment

Principal Investigator: Elizabeth Kessler
Protocol #19-0987, No Longer Enrolling: 4/13/2021
Locations: Department Specific Free Standing Clinic; University of Colorado Hospital;

A Phase 1 Multi-Targeted Study to Promote Anti-Tumor Immunity in ER Positive, HER2 Negative Advanced Breast Cancer

Principal Investigator: Jennifer Diamond
Protocol #20-0036, No Longer Enrolling: 8/10/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04132817

A Phase 2 Study Examining AGEN2034 as a Single-Agent and in Combination with AGEN1884 in Patients with Recurrent, Inoperable Angiosarcoma

Principal Investigator: Breelyn Wilky
Protocol #20-0261, No Longer Enrolling: 5/18/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04607200

POLATUZUMAB PLUS BENDAMUSTINE PLUS RITUXIMAB (POLA+BR) AS SALVAGE THERAPY PRIOR TO AUTOLOGOUS STEM CELL TRANSPLANT FOR PATIENTS WITH RELAPSED OR PRIMARY REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA

Principal Investigator: Derek Schatz
Protocol #19-1195, No Longer Enrolling: 1/30/2021
Locations: Lone Tree Medical Center; University of Colorado Hospital; University of Michigan;

More information available at ClinicalTrials.gov: NCT04535102

A Prospective Registry Study to Evaluate the Effect of the DCISionRT Test on Treatment Decisions in Patients with DCIS Following Breast Conserving Therapy

A Prospective Registry Study to Evaluate the Effect of the DCISionRT Test on Treatment Decisions in Patients with DCIS Following Breast Conserving Therapy

Principal Investigator: Alicia Deschaine
Protocol #20-1420, No Longer Enrolling: 6/30/2021
Locations: Memorial Hospital Central; Memorial Hospital North;

More information available at ClinicalTrials.gov: NCT03448926

A Phase 3, Randomized, Double-blind Trial of Nivolumab in Combination with Intravesical BCG versus Standard of Care BCG Alone in Participants with High-risk Non-muscle Invasive Bladder Cancer That Is Persistent or Recurrent After Treatment with BCG

Principal Investigator: Elizabeth Kessler
Protocol #20-0003, No Longer Enrolling: 6/4/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04149574

A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants with Melanoma (KEYNOTE-U02): Substudy 02A

Principal Investigator: Emma Martin
Protocol #20-0233, No Longer Enrolling: 4/16/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04305041

Pathogen Identification in Pediatric Hematopoietic Stem Cell Transplant Patients with Suspected Lower Respiratory Tract Infection (PBMTC SUP1601)

Principal Investigator: AMY KEATING
Protocol #17-1337, No Longer Enrolling: 4/30/2021
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT02926612

An Open-label Phase 1b Study of ORIC-101 in Combination with Anticancer Therapy in Patients with Advanced or Metastatic Solid Tumors

Principal Investigator: Kayla Rink
Protocol #20-2733, No Longer Enrolling: 10/13/2021
Locations: Outpatient CTRC; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03928314

A081801 - INTEGRATION OF IMMUNOTHERAPY INTO ADJUVANT THERAPY FOR RESECTED NSCLC: ALCHEMIST CHEMO-IO

Principal Investigator: Jasmine Singh
Protocol #20-2646, No Longer Enrolling: 10/23/2021
Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04267848

A phase II, open label, multi-center trial to determine the efficacy and safety of tisagenlecleucel re-infusion in Pediatric and Adolescent Young Adult (AYA) patients with acute lymphoblastic leukemia experiencing loss of B cell aplasia

Principal Investigator: AMY KEATING
Protocol #20-1441, No Longer Enrolling: 9/29/2021
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT04225676

A Randomized, Open Label Phase 3 Study Evaluating Safety and Efficacy of Venetoclax in combination with Azacitidine after allogeneic Stem Cell Transplantation in Subjects with Acute Myeloid Leukemia (AML) (VIALE-T)

Principal Investigator: Derek Schatz
Protocol #20-1970, No Longer Enrolling: 8/19/2021
Locations: Outpatient CTRC; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04161885

Evaluating the safety of weekly paclitaxel with trastuzumab duocarmazine (SYD985) in patients with metastatic cancer: A Phase I/Ib trial

Principal Investigator: Anthony Elias
Protocol #21-3259, No Longer Enrolling: 11/19/2021
Locations: Lone Tree Medical Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04602117

A randomized, multicenter, double-blind Phase 3 study of amcenestrant (SAR439859) plus palbociclib versus letrozole plus palbociclib for the treatment of patients with ER (+), HER2 (-) breast cancer who have not received prior systemic anti-cancer treatment for advanced disease

Principal Investigator: Leah Adams
Protocol #20-2060, No Longer Enrolling: 11/17/2021
Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04478266

GRADE: The Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study.

Principal Investigator: Chantal Underkofler
Protocol #13-0131, No Longer Enrolling: 6/10/2021
Locations: CTRC-adult; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT01794143

D2D: Vitamin D and Type 2 Diabetes

To assess whether, in participants with pre-diabetes, oral daily vitamin D3 (cholecalciferol) supplementation reduces the rate of progression from prediabetes to diabetes.

Protocol #14-2402, No Longer Enrolling: 11/14/2019
Locations: CTRC-adult; University of Colorado Hospital;

Comparison of Weight Loss Induced by Intermittent Fasting Versus Daily Caloric Restriction in Individuals with Obesity: A 1-Year Randomized Trial

This study plans to learn more about the best eating patterns for weight loss. Specifically, this study is being done to try to determine if intermittent fasting is as effective for weight loss as daily calorie restriction. In this study, we will be evaluating how your body weight, body composition, laboratory values, energy expenditure, and eating and exercise behaviors change during a 12-month weight loss program. We will also evaluate how your biology, life experiences, thought processes, behaviors, and environment predict how much weight you lose and how well you follow the diet and exercise recommendations in the study.

Principal Investigator: Kristen Bing
Protocol #17-0369, No Longer Enrolling: 6/15/2021
Locations: Anschutz Health and Wellness; UCD Anschutz Health & Wellness Center; University of Colorado Hospital;

A Phase III, multi-center, randomized, double-blind, 48 week study with an initial 12 week placebo-controlled period to evaluate the safety and efficacy of osilodrostat in patients with Cushing's disease

This study is a clinical research study consisting of 2 different periods (in the Core phase) with a total expected duration of 48 weeks and the first 12 weeks being a double-blind placebo controlled portion and then 36 weeks of study drug treament, followed by an optional extension phase for an additional 52 weeks (in which case the total duration of study participation will be up to 100 weeks). It is sponsored by the pharmaceutical company named Novartis (the ?Sponsor?). Around 69 patients will join this study in approximately 35 centers located in different countries (around 12) across the world. The purpose of this study is to confirm the effectiveness and safety of osilodrostat in treating patients with Cushing's Disease.

Principal Investigator: Janice Kerr
Protocol #17-0483, No Longer Enrolling: 3/10/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02697734

A Phase 3, Randomized, Double--Blind, Placebo--Controlled, Multicenter Study to Evaluate Efficacy and Safety of Octreotide Capsules in Patients Who Previously Tolerated and Demonstrated Biochemical Control on Injectable Somatostatin Receptor Ligands (SRL) Treatment

Principal Investigator: Ashley Pratt-Cordova
Protocol #17-0399, No Longer Enrolling: 2/10/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03252353

A Phase 2, Multicenter, Randomized, Single-Blind, Placebo-Controlled Cross-over Study to Assess the Efficacy and Safety of Exendin 9-39 in Patients with Postbariatric Hypoglycemia

Principal Investigator: Emma Hulseberg-Dwyer
Protocol #17-0366, No Longer Enrolling: 7/22/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03373435

A PHASE 2, RANDOMIZED, PLACEBO CONTROLLED STUDY OF SAFETY AND EFFICACY FOLLOWING REPEAT-DOSE ADMINISTRATION OF EVINACUMAB (ANTI ANGPTL3) IN PATIENTS WITH SEVERE HYPERTRIGLYCERIDEMIA (SHTG) AT RISK FOR ACUTE PANCREATITIS (R1500-HTG-1522)

Principal Investigator: Chantal Underkofler
Protocol #17-2118, No Longer Enrolling: 1/6/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03452228

A Double Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of ISIS 766720 (IONIS GHR-LRX, an Antisense Inhibitor of the Growth Hormone Receptor) Administered Once Every 28 Days for 16 Weeks in Patients with Acromegaly Being Treated with Long-acting Somatostatin Receptor

Principal Investigator: Benjamin Echalier
Protocol #18-0756, No Longer Enrolling: 2/10/2021
Location: University of Colorado Hospital;

The Effect of Exercise on Sleep Quality and Nocturnal Fat Oxidation in Individuals with Metabolic Syndrome

Principal Investigator: Jennifer Blankenship
Protocol #18-0369, No Longer Enrolling: 5/13/2021
Location: University of Colorado Hospital;

A PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY

Principal Investigator: Sharolene Goodman
Protocol #18-2230, No Longer Enrolling: 10/26/2020
Location: Childrens Hospital Colorado;

A Phase 2, Interventional, Randomized, Double Blind, Placebo-Controlled Pilot Study of Glucagon RTU in Subjects Who Experience Hyperinsulinemic Hypoglycemia After Bariatric Surgery

Protocol #18-1934, No Longer Enrolling: 10/8/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03770637

A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic Gastroparesis

Principal Investigator: Chantal Underkofler
Protocol #18-2435, No Longer Enrolling: 10/6/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03285308

Long term comparative effectiveness of once weekly semaglutide versus standard of care in a real world adult US population with type 2 diabetes - a randomized pragmatic clinical trial

Principal Investigator: Chantal Underkofler
Protocol #19-0120, No Longer Enrolling: 5/13/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03596450

A Phase 2, Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Adult Subjects with Congenital Adrenal Hyperplasia V: 2Feb2018

Principal Investigator: Marcie Terry
Protocol #17-1543, No Longer Enrolling: 8/29/2020
Location: Childrens Hospital Colorado;

A Two-Period, Open-label Trial Evaluating the Efficacy and Safety of Dasiglucagon for the Treatment of Children with Congenital Hyperinsulinism

Principal Investigator: Kathleen Peoples
Protocol #18-2130, No Longer Enrolling: 12/21/2020
Location: Childrens Hospital Colorado;

TESTO: Testosterone Effects on Short Term Outcomes in Infants with XXY V:10/5/2017

Principal Investigator: Shanlee Davis
Protocol #17-1317, No Longer Enrolling: 8/20/2021
Locations: Childrens Hospital Colorado; Department Specific Free Standing Clinic;

A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (!Y10 to <18 years) with Type 2 Diabetes Mellitus

Principal Investigator: Kaylene Ross
Protocol #17-1809, No Longer Enrolling: 5/12/2021
Location: Childrens Hospital Colorado;

A Phase 3, Multicenter, Open-Label, Two-Part Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Leuprolide Acetate 45 mg 6-Month Depot Formulation in Children with Central Precocious Puberty (CPP)

Principal Investigator: Marcie Terry
Protocol #18-1716, No Longer Enrolling: 12/7/2020
Location: Childrens Hospital Colorado;

The impact of feminizing gender-affirming hormone therapy on biomarkers of coagulation and thrombosis

We are enrolling transgender women who are starting feminizing Gender Affirming Hormone Therapy (e.g., estrogen plus spironolactone). They are adults who were assigned male at birth but whose gender identity is female. The global aim of this pilot study is to determine whether estrogen plus spironolactone increases levels of certain biomarkers of coagulation and thrombosis in trans women or other persons taking estrogen plus spironolactone for feminizing Gender Affirming Hormone Therapy after six months and twelve months.

Principal Investigator: Sean Iwamoto
Protocol #20-0104, No Longer Enrolling: 6/19/2021
Location: University of Colorado Hospital;

A Proof-of-Concept Study Examining the Addition of Yoga to a Behavioral Weight Loss Intervention on Energy Balance and Health-Related Outcomes

Participation will include: Blood draws and questionnaires; Assessments of body composition, energy metabolism, and glucose control; Membership to the Anschutz Health and Wellness Center; Monetary compensation

Principal Investigator: Ann Caldwell
Protocol #21-3690, No Longer Enrolling: 10/23/2021
Locations: Outpatient CTRC; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT05031221

The Colonic Microbiome and Mucosal Immunity in Inflammatory Bowel Disease and Ankylosing Spondylitis

This study uses colonic biopsies to compare immune cell function and gut microbiome between those with IBD, AS, AS/IBD overlap, and healthy controls.To evaluate the relationship between the colonic microbiome and the immune system in AS, IBD, AS+IBD, and healthy controls.

Principal Investigator: Andrew Stahly
Protocol #14-1507, No Longer Enrolling: 7/6/2021
Locations: Colorado Research Center; Denver Health and Hospital Authority; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02389075

A Randomized, Open-label, Phase 2 Study to Evaluate Safety and Efficacy of DUR-928 in Subjects with Primary Sclerosing Cholangitis (PSC)

DUR-928 (investigational drug)

Principal Investigator: Lisa Forman
Protocol #18-0123, No Longer Enrolling: 1/6/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03394781

An Open-Label, Multicenter and Open Enrollment Model, Postmarketing, Milk-Only Lactation Study to Assess Concentration of Vedolizumab in Breast Milk of Lactating Women With Active Ulcerative Colitis or Crohn's Disease Who Are Receiving Vedolizumab Therapeutically

The safety of medications to treat UC and CD during pregnancy and lactation is of significant interest of childbearing potential, as these medications may be transferred in utero or though breast milk form nursing mothers to their newborns. It is unknown whether vedolizumab is present in human breast milk.

Principal Investigator: Blair Fennimore
Protocol #16-0066, No Longer Enrolling: 6/9/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02559713

An Observational Cohort Study of the Use of Avatrombopag in Patients with Thrombocytopenia Associated with Chronic Liver Disease Undergoing a Procedure

Principal Investigator: John Norvell
Protocol #18-1144, No Longer Enrolling: 1/6/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03554759

A Multicenter, Double-Blind, Parallel-Arm, Placebo-Controlled Phase 2 Study of the Efficacy, Safety, and Tolerability of Oral Full-Spectrum Microbiota? (CP101) in Subjects with Recurrence of Clostridium difficile Infection (2/22/2018 version 3)

This is a double-blind, placebo-controlled, parallel-arm, multicenter study comparing the safety, tolerability, and efficacy of CP101 treatment relative to placebo in adults with previously treated recurrent CDI. Subjects who are experiencing recurrent CDI will undergo screening procedures. Subjects who meet eligibility criteria will be randomized to study drug. Approximately 200 subjects (100 subjects per treatment group) will be randomized in a 1:1 ratio to receive CP101 (6  1011 bacteria) or placebo. The treatment duration will be 1 day, including active drug (CP101) and placebo. Subjects will be monitored for recurrence of CDI, safety, and tolerability for 24 weeks following Randomization. The primary efficacy and safety endpoints will be evaluated at 8 weeks post-treatment, and all subjects will continue to be followed for an additional 16 weeks for safety and recurrence of CDI. To qualify for the study, subjects must be experiencing recurrent CDI defined as: a)  3 episodes of CDI, with 2 episodes occurring within the previous 12 months (inclusive of the current episode); OR b) 2 episodes of CDI occurring within the previous 6 months (inclusive of the current episode) AND 65 years of age or older. Additionally, to qualify, recurrent CDI subjects must have received standard-of-care CDI antibiotics for the most recent CDI episode (for 10-21 days, with exact duration, antibiotic type, and dose at the discretion of the Investigator) and have an adequate clinical response, defined as  3 unformed stools in 24 hours for 2 or more consecutive days immediately prior to Randomization.

Principal Investigator: Shelby Sullivan
Protocol #18-1166, No Longer Enrolling: 9/28/2021
Locations: Outpatient CTRC; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03497806

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial of Oral IW-3718 Administered to Patients with Gastroesophageal Reflux Disease while receiving Proton Pump Inhibitors

The Treatment Period begins with treatment assignment and lasts for 8 weeks. Patients will be stratified by whether they have, or do not have, erosive esophagitis on the screening EGD, and by their baseline heartburn severity level (average heartburn severity score over the last 7 days prior to randomization of <3 vs. ≥3; see Criteria for Evaluation, below) and randomly assigned within each stratum to placebo or 1500 mg IW-3718 BID (1:1). The treatment randomization schedule will be managed by a central vendor. Enrollment will be monitored to ensure that no single center contributes > 10% of the targeted study enrollment, unless otherwise approved by the Medical Monitor. Study drug will be taken immediately after the morning and evening meals. Patients will continue to take their PPI approximately 30-60 minutes before breakfast each day and to use the eDiary to provide their daily assessments (GERD symptoms and assessment of sleep), weekly assessments (degree of relief of GERD symptoms, symptom bothersomeness, and treatment satisfaction questions). At the end of the treatment period study medication will be discontinued and patients will return for an End-of-Treatment (EOT) Visit. All patients who have erosive esophagitis (LA classification A-D) on EGD at Screening and completed ≥4 weeks of treatment will have a repeat EGD at their EOT Visit. Patients will also complete all End-of-Treatment assessments

Principal Investigator: Paul Menard-Katcher
Protocol #18-2021, No Longer Enrolling: 6/10/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03327727

EA2187: "A Phase 2 Study of Pevonedistat in Combination with Carboplatin and Paclitaxel in Advanced Intrahepatic Cholangiocarcinoma"

Principal Investigator: Nathan Ketelhut
Protocol #20-0584, No Longer Enrolling: 4/2/2021
Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital;

More information available at ClinicalTrials.gov: NCT04175912

A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Sclerosing Cholangitis (VISTAS)

Volixibat is an experimental treatment, meaning that it has not yet been approved by the US Food and Drug Administration or any worldwide regulatory body. Volixibat is a medicine that lowers circulating bile acid levels that are believed to lead to the itching in patients with PSC. There are no other medicines approved to treat itching in patients with PSC. This is the first time volixibat will be used in patients with PSC. In the first part of this study, called the “Core Study,” the study medicine will be compared with a placebo for a period of 28 weeks. A placebo is a capsule that looks exactly like the study medicine but does not contain any active ingredient. At any time during this part of study, you may be given volixibat or placebo. Whether you receive volixibat or placebo will be decided randomly (by chance, like flipping a coin/rolling a die). In the Core Study, between 50% and 67% of participants will receive volixibat. To make this study fair, for part of the study, you and the study doctor will not be told which medicine or placebo you will receive. This is called “blinding.” In case of an emergency, the study doctor will be able to look up the medicine or placebo you are taking/receiving at any time. In the next part of this study, called the “Open-Label Extension,” all eligible participants who choose to continue will receive volixibat for up to 2 years. The primary and secondary objectives and endpoints will be evaluated in participants with PSC who have a baseline score of ≥4 on the Adult Itch-Reported Outcome (ItchRO), as assessed during the single-blind, placebo run-in period during the core study.

Principal Investigator: Aryana Rasti
Protocol #20-2820, No Longer Enrolling: 11/1/2021
Locations: Outpatient CTRC; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04663308

A PROSPECTIVE, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, MULTICENTER, PHASE 3 EFFICACY AND SAFETY STUDY OF OTO-104 GIVEN AS A SINGLE INTRATYMPANIC INJECTION IN SUBJECTS WITH UNILATERAL MENIERE'S DISEASE

Participants will come into the clinic for 5 visits which will last 1.5-3.5 hours long. Each visit has an Audiologist and an Otologist component in it. Each participant will need to complete daily diary entries by calling into phone number and answering some questions.

Principal Investigator: Kristi Engle Folchert
Protocol #18-1269, No Longer Enrolling: 3/2/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03664674

Laryngeal Chemosensation: A Pilot Study

Principal Investigator: Laura Temple
Protocol #18-1057, No Longer Enrolling: 12/3/2019
Location: University of Colorado Hospital;

A 24-Week Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study Evaluating the Efficacy and Safety of Intranasal Administration of 186 and 372 ?g of OPN-375 Twice a Day (BID) in Subjects with Chronic Sinusitis With or Without the Presence of Nasal Polyps

OptiNose intends to study the efficacy and safety of OPN-375 in subjects with chronic sinusitis.

Principal Investigator: James Manor
Protocol #18-2823, No Longer Enrolling: 9/17/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03781804

Evaluation of AutoSense OS on a Naida CI M90 Sound Processor Programmed with Target CI Fitting Software in Adult Users of the HiResolution Bionic Ear System

Principal Investigator: Laura Temple
Protocol #19-2598, No Longer Enrolling: 7/23/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04237207

Colorado Oral Strengthening Device

A new study is looking at a device that would strengthen the muscles of the mouth to make eating and drinking easier for those who have trouble swallowing. Participants will be randomized to either the group using the investigational device for tongue exercise or the group using standard of care tongue depressors. All participants will receive compensation for participating. To develop a low-cost device that improves patient outcomes by eliciting the same methods of action of existing higher cost devices. To assess if exercising the tongue with this novel device can achieve increased tongue strength among individuals with Parkinson's disease.

Principal Investigator: Laura Temple
Protocol #19-1850, No Longer Enrolling: 11/18/2020
Location: University of Colorado Hospital;

Development and Content Validation of Instruments to Screen for and Assess Severity of Tinnitus in Young People

Principal Investigator: Natalie Macaruso
Protocol #19-2940, No Longer Enrolling: 4/28/2021
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT00000000

An Observational, Multicenter Study of the Prevalence of Cerebrotendinous Xanthomatosis (CTX) in Patient Populations Diagnosed with Early-Onset Idiopathic Bilateral Cataracts

Principal Investigator: Emily Mccourt
Protocol #16-0145, No Longer Enrolling: 2/10/2021
Location: Childrens Hospital Colorado;

Phase I Study of Feasibility and Safety of UCD19 Chimeric Antigen Receptor (CAR) T Cells in Adult Subjects with Relapsed/Refractory (R/R) B-Cell Non-Hodgkin's Lymphoma (B-NHL)

Principal Investigator: Derek Schatz
Protocol #19-2807, No Longer Enrolling: 6/6/2020
Locations: Lone Tree Medical Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04240808

The effect of isotretinoin on the etonogestrel contraceptive implant

Principal Investigator: Aaron Lazorwitz
Protocol #16-0614, No Longer Enrolling: 8/18/2021
Locations: Comprehensive Women's Health Center; Comprehensive Womens Health Center;

Dysregulation of FSH in Obesity: Functional and Statistical Analysis

This study plans to learn more about the relationship between fertility and obesity.

Principal Investigator: Alex Polotsky
Protocol #15-0474, No Longer Enrolling: 3/2/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02478775

The Cellular Pharmacology of F-TAF in dried blood spots

The goal of this study is to vary the amount of F-TAF dosing and see if the drug levels in dried blood spots (DBS) change in a predictable way.

Protocol #16-0972, No Longer Enrolling: 10/16/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02962739

Myeloid to Adipocyte Transdifferentiation in Human cells

If you join the study, you will complete the following research procedures over the course of 2 study visits: Informed consent, physical exam and medical history, body composition test, blood draw and fat biopsy.This research study plans to learn more about where the fat cells in your body come from. Understanding the origin of fat cells is important because it may help to determine the health of fat cells and why fat that is stored in some places of your body is more "unhealthy" than other fat.

Principal Investigator: Kathleen Gavin
Protocol #15-1779, No Longer Enrolling: 6/16/2021
Locations: Outpatient CTRC; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02654925

Validation of a method for isotopic analysis in human plasma samples V:04/20/2018

Principal Investigator: Ed Melanson
Protocol #16-2739, No Longer Enrolling: 4/30/2021
Location: University of Colorado Hospital;

Effects of Ovarian Hormone Suppression on Vascular and Cognitive Function

Principal Investigator: Kerry Hildreth
Protocol #17-0092, No Longer Enrolling: 6/17/2021
Location: University of Colorado Hospital;

Mechanisms for Sleep/Circadian Disruption-Induced Impairments in Bone Formation

We are looking for healthy men to participate in a research study on the effects of sleep restriction on bone. The purpose of this research is to understand how shortened sleep affects bone metabolism. The study includes an intervention phase consisting of a 1-week outpatient and 8-night inpatient stay. Participants will be observed after discharge from the intervention phase for 3 weeks. Principal Investigator, Christine Swanson, MD, MCR (COMIRB #18-0015)

Principal Investigator: Christine Swanson
Protocol #18-0015, No Longer Enrolling: 10/8/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03733483

Effect of freestyle skiing on bone mineral density

Principal Investigator: Ilona Schwarz
Protocol #19-0802, No Longer Enrolling: 2/21/2020
Locations: Barbara Davis Center; UCD Barbara Davis Center;

Use of accelerometers to improve estimation of the thermic effect of feeding in whole room calorimetry studies

What you receive for participating: -Personalized information about your energy expenditure ("metabolism") -Five total days of food -Monetary compensationTest whether accelerometer-based measures of physical activity from Actigraph and ActivPAL accelerometers can be used to improve the calculation of TEF in whole room calorimeter studies.

Principal Investigator: Sarah Purcell
Protocol #20-0191, No Longer Enrolling: 9/3/2021
Location: University of Colorado Hospital;

The HPV 9-10 Trial: Early Initiation of HPV Vaccination

Principal Investigator: Alison Saville
Protocol #19-3006, No Longer Enrolling: 2/4/2021
Locations: CHOC ? Children?s Hospital of Orange County; UCLA - University of California; UCLA, Jonsson Cancer Center; University of Colorado Hospital;

Measurement of Hematopoietic Stem Cell Derived Adipocytes

The purpose of this study is to learn more about where the fat tissue in your body originates. For many years it has been thought that all fat cells come from cells that are from the fat tissue itself, but now we know it is possible that some fat cells may originally come from the bone marrow. Understanding the origin of fat cells is important because it may help to determine the health of fat cells. You are being asked to be in this research study because you are a person over the age of 18 who has had a hematopoietic stem cell transplant or has chronic phase chronic myeloid leukemia (CML). To understand if some fat cells (adipocytes) may originally come from cells in the bone marrow. Understanding the origin of fat cells is important because it may help to determine the health of fat cells and why fat that is stored in some places of your body is more unhealthy than other fat.

Principal Investigator: Dwight Klemm
Protocol #13-0026, No Longer Enrolling: 8/19/2021
Location: University of Colorado Hospital;

Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure-Connect-HF

Principal Investigator: Benjamin Echalier
Protocol #17-0423, No Longer Enrolling: 1/6/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03035474

Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure

Assess your medical care Help researchers better understand your medical treatment and health outcomes Provide an understanding on how diseases impact your daily life Provide you with more information about heart disease

Principal Investigator: Alicia Gneiting
Protocol #17-6148, No Longer Enrolling: 6/27/2020
Location: Memorial Hospital Central;

Randomized Observation of Biventricular pacemakers on ventrIcular function among patients with mechaNical circulatory support devices: "ROBIN"

Principal Investigator: Gregory Coe
Protocol #17-1042, No Longer Enrolling: 7/6/2021
Locations: CTRC Inpatient; University of Colorado Hospital;

A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection Fraction

Principal Investigator: Amrut Ambardekar
Protocol #17-1343, No Longer Enrolling: 1/15/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02929329

Real-time Electrogram Analysis for Drivers of Atrial Fibrillation

Protocol #17-1506, No Longer Enrolling: 11/14/2019
Location: University of Colorado Hospital;

Observational Registry of Treatment Patterns in U.S. Heart Failure Patients with Reduced Ejection Fraction

The objective of this study is to understand real-world treatment patterns, as well as the reasons and barriers for treatment changes in heart failure patients with reduced ejection fraction.

Principal Investigator: Alicia Gneiting
Protocol #16-6062, No Longer Enrolling: 5/20/2020
Location: Memorial Hospital Central;

A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients who have Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement

The purpose of this trial is to establish the safety and efficacy of the Edwards SAPIEN 3 THV device in patients with severe, calcific, aortic stenosis who are at low operative risk for SAVR.

Protocol #16-6069, No Longer Enrolling: 10/1/2019
Locations: Harmony Campus; Medical Center of the Rockies;

More information available at ClinicalTrials.gov: NCT02675114

MOMENTUM 3 Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy with HeartMate 3?

Principal Investigator: Alisha Shudy
Protocol #16-2506, No Longer Enrolling: 10/9/2021
Location: University of Colorado Hospital;

Watchman for patients with atrial fibrillation undergoing transcatheter aortic valve replacement

WATCH-TAVR is a prospective, multicenter, randomized event-driven controlled trial.

Principal Investigator: Darcee Robeson
Protocol #18-6002, No Longer Enrolling: 11/7/2020
Locations: Harmony Campus; Medical Center of the Rockies;

More information available at ClinicalTrials.gov: NCT03173534

Multiple cArdiac seNsors for mAnaGEment of Heart Failure (MANAGE-HF)

The MANAGE-HF study is a multi-center, global, prospective, open label, multi-phase trial. Phase I will be non-randomized. Phase II will be randomized.1) To evaluate and optimize HeartLogic? Heart Failure Diagnostics (called HeartLogic from here on) clinical integration and the alert management process (Phase I) 2. To evaluate HeartLogic in regards to patient outcomes of death and heart failure hospitalizations (Phase II)

Principal Investigator: Janice Huang
Protocol #18-6028, No Longer Enrolling: 5/20/2020
Locations: Memorial Hospital Central; Memorial Hospital North;

More information available at ClinicalTrials.gov: NCT03237858

Assessment of the Watchman Device in Patients Unsuitable for Oral Anticoagulation

This study is a prospective, randomized, multi-center, global investigation to determine the safety and effectiveness of the WATCHMAN Device for subjects with non-valvular atrial fibrillation who are deemed not suitable for anticoagulation therapy to reduce the risk of stroke.

Principal Investigator: Brad Mikaelian
Protocol #18-6501, No Longer Enrolling: 1/21/2020
Location: Memorial Hospital Central;

More information available at ClinicalTrials.gov: NCT02928497

An Open-Label Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Subjects with Thrombocytopenia Scheduled for a Surgical Procedure

The purpose of this study is to test the safety and effectiveness of the study drug, avatrombopag, in subjects with thrombocytopenia undergoing an operation. Patients will receive either 60mg or 80mg of avatrombopag once daily by mouth for 5 days prior to surgery

Principal Investigator: Jennifer Maitlen
Protocol #18-0546, No Longer Enrolling: 9/15/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03326843

A Randomized, Double-Blind, Parallel Group, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of Once Weekly Subcutaneous Injections of a Sustained-Release VIP Analogue, PB1046, in Adult Subjects with Symptomatic Pulmonary Arterial Hypertension

Once the subject meets entry criteria, the study will enroll into a 25 week study. The subject will have subcutaneous injections once weekly and be expected to return to clinic every 6 weeks. The other weekly visits can be done in the subject's location of choice (i.e. home/work). There are multiple blood draws required for this study at certain time points. Other procedures that the subject will complete during the study are: a complete physical exam, EKGs, laboratory assessments, 6 minute walks, 2 right heart caths - one at the beginning and one at the end of the study and daily blood pressures. The subject will be given a home B/P monitor to use. During this study, the subject has a 66% chance of getting active study drug and a 33% change of getting a placebo. Once the subject completes the study, the subject will have the option to enroll into the open label study during which he/she will be given the active study drug.

Protocol #18-0915, No Longer Enrolling: 10/1/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03556020

A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of CSL112 in Subjects with Acute Coronary Syndrome

If you agree to join the study, screening tests will be performed while you are in the hospital to assess your eligibility for the study. If you are eligible to take part in the study, you will be randomized to receive either the study drug or placebo. ?Randomized? means that you will be assigned by chance, like flipping a coin, to take the study drug (CSL112) or the placebo. You will have a 50/50 chance of receiving either CSL112 or placebo. Both the study drug and placebo will be given by intravenous (IV) infusion which means slowly pumping the drug into your body through a small tube that is inserted into a vein. The infusion will last approximately 2 hours. You will receive up to four (4) infusions of either the study drug or placebo weekly for 4 weeks; each infusion is to be given at least 5 days apart. All 4 infusions should be administered within 30 days of you receiving your first infusion. Additional study visits will occur throughout the next year to assess for any new health problems, side effects, or changes in your medical conditions. This is a double-blind study, which means you, your Study Doctor, and the study staff will not know which treatment you are getting, but your Study Doctor can find out if there is an emergency, if it is critical to know for your health, or after the study has ended and the results have been analyzed. Your participation in the study will be approximately 1 year (365 days). This includes the Screening Period (1 visit), an Active Treatment Period (which includes 4 weekly infusion visits and a follow-up visit for safety) and a Follow-Up Period (which includes 5 visits) to assess any new health problems or side effects you may have experienced since your last study visit and your overall well-being. This study will have 11 study visits, 2 of which may be conducted by telephone during the Follow-Up period.

Principal Investigator: James Strader
Protocol #18-6051, No Longer Enrolling: 8/12/2020
Location: Memorial Hospital Central;

More information available at ClinicalTrials.gov: NCT03473223

EMPERIAL-preserved: A phase III randomized, double-blind trial to evaluate the effect of 12 weeks treatment of once daily EMPagliflozin 10 mg compared with placebo on ExeRcise ability and heart failure symptoms, In patients with chronic HeArt FaiLure with preserved Ejection Fraction (HFpEF)

Subjects enrolled in this trial will be randomly assigned to receive either Empagliflozin 10 mg or placebo for 12 weeks.

Principal Investigator: Chantal Underkofler
Protocol #18-0925, No Longer Enrolling: 9/9/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03448406

EMPERIAL-reduced: A phase III randomized, double-blind trial to evaluate the effect of 12 weeks treatment of once daily EMPagliflozin 10 mg compared with placebo on ExeRcise ability and heart failure symptoms, In patients with chronic HeArt FaiLure with reduced Ejection Fraction (HFrEF)

Participants will be randomly assigned to empagliflozin or placebo. Participants will take the study medication (empagliflozin or placebo) for 12 weeks.

Principal Investigator: Chantal Underkofler
Protocol #18-0926, No Longer Enrolling: 9/9/2021
Locations: Outpatient CTRC; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03448419

A phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy and safety of CSL112 in subjects with acute coronary syndrome.

The primary objective of this study is to evaluate the efficacy of CSL112 on reducing the risk of MACE (CV death, MI, or stroke) from the time of randomization through 90 days in subjects with ACS (diagnosed with STEMI or NSTEMI)

Principal Investigator: Dori Burnette
Protocol #18-6081, No Longer Enrolling: 4/13/2021
Locations: Harmony Campus; Medical Center of the Rockies;

More information available at ClinicalTrials.gov: NCT03473223

GB001-1101:A Phase 1b, Randomized, Subject- and Investigator-Blinded, Placebo-Controlled, Multi-Center Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Biomarkers of Inhaled GB002 in Subjects with WHO Group 1 Pulmonary Arterial Hypertension (PAH)

This is a multicenter, randomized, blinded and placebo controlled study in subjects with WHO group 1 Pulmonary Arterial Hypertension who will recieve inhaled GB002 or matching placebo for 14 days. The subject will have to visit the clinic for screening and on days 1, 2, 8 and 14. The patient has the option of having a visiting nurse come to them on days 3 to 7 to verify that they are following instrctions for dosing of the study drug and completing their study diary correctly. There will also be a follow up telephone call on days 15 and 42 to assess the patient's physical status and record any additional medications being taken. On day 1 and day 14, the visit will last up to 6 hours and the patient will have 5 blood draws during that time to assess drug levels in the blood and on days 2 and 8, the visi will last up to 2 hours and the patient will have one blood level drawn on these days.

Principal Investigator: Cheryl Abbott
Protocol #18-2672, No Longer Enrolling: 6/16/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03926793

Prospective, multicenter, Single Arm Safety and Effectiveness Confirmatory Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellis System

Patients diagnosed with an abdominal aortic or aortoiliac aneurysm who are considered candidates for endovascular repair and who meet the study eligibility criteria may be screened for enrollment in the study

Principal Investigator: David Corry
Protocol #19-6501, No Longer Enrolling: 6/24/2020
Location: Memorial Hospital Central;

More information available at ClinicalTrials.gov: NCT03298477

A PROSPECTIVE, MULTI-CENTER, SINGLE ARM STUDY TO OBTAIN "REAL WORLD" CLINICAL DATA AND CHARACTERIZE THE ACUTE AND LONG-TERM PERFORMANCE OF THE MICRUSFRAME AND GALAXY COILS FOR THE ENDOVASCULAR TREATMENT OF INTRACRANIAL ANEURYSMS

A Prospective, Multi-Center, Single Arm Study to obtain “Real World” Clinical Data and Characterize the Acute and Long-Term Performance of the Micrusframe and Galaxy Coils for the Endovascular Treatment of Intracranial Aneurysms

Principal Investigator: Rebekah Graner
Protocol #19-6503, No Longer Enrolling: 4/4/2020
Location: Memorial Hospital Central;

More information available at ClinicalTrials.gov: NCT03642639

Edwards Cardioband System ACTIVE Pivotal Clinical Trial

The ACTIVE Trial is a prospective, randomized, multicenter trial. Patients with clinically significant functional mitral regurgitation will be randomized 2:1 to receive either transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT) or GDMT alone.

Protocol #17-2107, No Longer Enrolling: 11/14/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03016975

The CLASP Study - Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study

The Edwards PASCAL System is intended for the percutaneous reconstruction of an insufficient mitral valve in patients with clinically significant, symptomatic mitral regurgitation and:  New York Heart Association (NYHA) Functional Class II, III and ambulatory IV heart failure  The primary regurgitant jet is non-commissural. If a secondary jet exists, it must be considered clinically insignificant

Principal Investigator: Gregory Coe
Protocol #18-0876, No Longer Enrolling: 1/6/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03170349

Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR)

This clinical study is a prospective, multicenter, single-arm clinical evaluation of the Multi-Electrode Radiofrequency (RF) Balloon catheter. The purpose of this study is to evaluate the overall safety and effectiveness of the Multi-Electrode RF Balloon catheter, in conjunction with the Multi-Electrode Circular Diagnostic catheter and Multi-Channel RF Generator, for the treatment of drug refractory Paroxysmal Atrial Fibrillation (PAF). Embedded within the Main Study will be a Neurological Assessment Evaluable (NAE) subset and a Cardiac Computed Tomography (CT) or Magnetic Resonance Angiogram (MRA) image (CT/MRA) subset with consecutive enrollment and a prospective design. The same subject can participate in both the NAE and cardiac CT/MRA subsets. The study will enroll subjects with drug refractory, symptomatic PAF who are candidates for catheter ablation. The first 1-3 subjects for each ablating physician will be considered roll-in subjects to verify consistent workflow for study device components and to minimize any learning curve effects. The roll-in subjects will not be included in the NAE subset, cardiac CT/MRA subset, or in the primary endpoint analyses. The roll-in phase will include a maximum of 240 subjects and the main study phase will include a maximum of 400 evaluable subjects. Subjects will be evaluated prior to the procedure, prior to discharge, and post procedure at 7 days (7-14 days), 1 month (23-37 days), 3 months (76- 104 days), 6 months (150-210 days), and 12 months (315-405 days) unless otherwise specified in the protocol.

Principal Investigator: Ryan Aleong
Protocol #19-1679, No Longer Enrolling: 4/17/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03683030

Comparison of Anticoagulation with Left Atrial Appendage Closure after AF Ablation

This is a study for patients that have a heart condition in which the upper chambers of your heart beat irregularly. This condition, also known as atrial fibrillation, can cause blood clots to form in an area of your heart called the left atrial appendage (LAA). Everyone has a LAA, which is like a pouch on the top of your heart, and it developed along with the other parts of the heart before birth. If a clot forms here, it can increase your chances of having a stroke or other related problems. Because you have atrial fibrillation, it is believed that if the LAA is closed, then blood clots might not be able to form in that area. The current standard of care to prevent stroke in patients with atrial fibrillation is long-term oral anticoagulation (OAC) therapy (blood thinner medication) or, in appropriately selected patients, implant of the commercial WATCHMANTM device followed by short-term OAC therapy.

Principal Investigator: Brad Mikaelian
Protocol #19-6506, No Longer Enrolling: 9/10/2021
Location: Memorial Hospital Central;

More information available at ClinicalTrials.gov: NCT03795298

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Impact of Evolocumab on Major Cardiovascular Events in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke

This is a clinical study sponsored by Amgen Inc. It is a study being done for patients that are at high risk for experiencing a cardiovascular event (like a heart attack or stroke). Elevated cholesterol, in particular low-density lipoprotein cholesterol (LDL-C), can lead to obstructing fatty deposits in blood vessels that can greatly increase the risk of developing cardiovascular disease or experiencing a cardiovascular event. The purpose of this research study is to assess whether lowering of cholesterol blood level can reduce your risk for major cardiovascular events (for example, heart attack or stroke) when evolocumab is taken in addition to current medical therapy as directed by a doctor, which may include a medication for the treatment of abnormal cholesterol blood levels called statins.

Principal Investigator: Alicia Gneiting
Protocol #19-6511, No Longer Enrolling: 11/19/2021
Location: Memorial Hospital Central;

More information available at ClinicalTrials.gov: NCT03872401

ECG Belt for CRT Response

Demonstrate benefit of using the ECG Belt Research System on reducing left ventricular end-systolic volume (LVESV) from baseline to 6 months post-implant compared to standard CRT. ECG Belt arm subjects will be compared with the control arm subjects (combined control arms A and B). A core lab blinded to randomization and follow up status will analyze the echo data and measure LVESV.Demonstrate benefit of using the ECG Belt Research System on reducing left ventricular end-systolic volume (LVESV) from baseline to 6 months post-implant compared to standard CRT. ECG Belt arm subjects will be compared with the control arm subjects (combined control arms A and B). A core lab blinded to randomization and follow up status will analyze the echo data and measure LVESV.

Principal Investigator: Rachael Burnett
Protocol #19-1703, No Longer Enrolling: 9/29/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03504020

PREcision Event Monitoring of PatienTs with Heart Failure using HeartLogic

You are being asked to participate in this research study because you have been diagnosed with heart failure and you are implanted with a commercially approved Boston Scientific Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy Defibrillator (CRT-D) device. Inside your device are sensors that monitor your heart failure condition. The purpose of this study is to better understand how sensor readings from your device relate to specific clinical events that you may experience during the time you are in the study. This information may be able to detect when your heart failure is getting worse earlier and with more accuracy. This could help your doctor treat your heart failure timely and with the appropriate treatments.

Principal Investigator: James Strader
Protocol #19-6516, No Longer Enrolling: 8/8/2020
Location: Memorial Hospital Central;

More information available at ClinicalTrials.gov: NCT03579641

Evaluation of the VISITAG SURPOINT Module with External Processing Unit (EPU) when used with the THERMOCOOL SMARTTOUCH SF and the THERMOCOOL SMARTTOUCH Catheters for Pulmonary Vein Isolation (PVI)

The SURPOINT COA study is a prospective, multicenter, non-randomized post-market clinical evaluation of the VISITAG SURPOINT™ Module with EPU when used with the STSF/ST catheters in treating subjects with symptomatic PAF who have failed at least one antiarrhythmic drug. A total of 330 subjects will be enrolled at up to 45 sites. Two hundred eighty (280) enrolled subjects will be treated using the STSF catheter with EPU and fifty (50) subjects will be treated with ST catheter. Prior to enrollment, a few sites will be selected to only enroll subjects who will be treated with the ST catheter and the remaining sites will only enroll subjects who will be treated with the STSF catheter. Effectiveness and safety endpoints have been defined, and will be compared to predetermined performance goals. Subjects who sign the SURPOINT COA informed consent are considered enrolled in the study. Enrolled subjects who satisfy all eligibility criteria will then undergo the ablation procedure with the catheter and VISITAG SURPOINT™ Module. After the study ablation procedure, subjects will enter a 3-Month blanking period (Day 0-90). After the Blanking Period, subjects will enter the Evaluation Period (Days 91-365). Subjects having AF recurrence and/or receiving therapeutic interventions during the evaluation period will be considered effectiveness failures (refer to Section 4.1.1 for all effectiveness failure modes). All subjects will undergo follow up visits at defined intervals (refer to Table 5-1 Schedule of Treatments and Evaluations). Subjects complete the SURPOINT COA study after the 12-month follow up visit.

Principal Investigator: Rachael Burnett
Protocol #19-0003, No Longer Enrolling: 9/29/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03624881

An Open-Label, Single Arm, Multicenter Study to Broaden Access to Emapalumab, an Anti-Interferon Gamma (Anti-IFNy) Monoclonal Antibody, and to Assess its Efficacy, Safety, Impact on Quality of Life, and Long-term Outcome in Pediatric Patients with Primary Hemophagocytic Lymphohistiocytosis

Principal Investigator: Tim Garrington
Protocol #19-0105, No Longer Enrolling: 6/9/2021
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT03312751

A Phase 3 Global, Double-Blind, Randomized, Placebo‑Controlled Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Transthyretin‑Mediated Amyloid Cardiomyopathy (ATTR CM)

Randomized, double-blind, placebo-controlled study of ION‑682884 vs. placebo administered by SC injection once every 4 weeks for 120 weeks in patients with ATTR-CM receiving available background SoC. Patients will be stratified at Randomization based on NYHA Classification (I and II vs. III), ATTR mutation status (mutated vs. wild-type), 6MWT (≤ 350 meters vs. > 350 meters), and current treatment with tafamidis (Yes vs. No). Study Drug (ION‑682884 or placebo) will be administered for 120 weeks (Treatment Period) followed by an additional 20 weeks of Post-Treatment Evaluation Period.

Principal Investigator: Amrut Ambardekar
Protocol #19-2854, No Longer Enrolling: 10/29/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04136171

A Randomized, Controlled Phase 3 Study of Pacritinib Versus Physician s Choice in Patients with Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post Essential Thrombocythemia Myelofibrosis with Severe Thrombocytopenia (Platelet Counts <50,000/μL)

Principal Investigator: Brandon McMahon
Protocol #19-2788, No Longer Enrolling: 7/24/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03165734

The Cardiovascular Multi-dimensional Observational Investigation of the Use of PCSK9 Inhibitors (cvMOBIUS)

While you are taking part in in the study, you will see your doctor as usual. Your doctor will make notes (medical records) about your disease and its treatment as he/she normally would. For the next 5 years, a study coordinator at your doctor’s office will collect information from your doctor’s notes about your medical condition and treatments, including any medication changes.

Principal Investigator: Rebekah Graner
Protocol #19-6518, No Longer Enrolling: 12/22/2020
Locations: Memorial Hospital Central; Memorial Hospital North;

More information available at ClinicalTrials.gov: NCT04197453

OPTION

This study is a prospective, randomized, multi-center, global investigation to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation in patients after AF ablation.

Principal Investigator: Alice Holmquist
Protocol #20-6502, No Longer Enrolling: 7/17/2021
Location: Medical Center of the Rockies;

More information available at ClinicalTrials.gov: NCT03795298

Scleroderma Lung Study III (SLS III): Combining the anti-fibrotic effects of pirfenidone (PFD) with mycophenolate (MMF) for treating scleroderma-related interstitial lung disease

Principal Investigator: Ashley Pratt-Cordova
Protocol #17-1226, No Longer Enrolling: 4/23/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03221257

A PHASE 2A, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF RSLV-132 IN SUBJECTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS

- assess the impact of 13 IV infusions of RSLV-132 on cutaneous lupus disease activity using the CLASI activity score. -assess improvement in disease activity using SLEDAI-2K, BILAG-2004 and PGA; - evaluate the immunogenicity of RSLV-132 in subjects with SLE; - assess improvement in tender or swollen joint count; - assess improvement in patient reported outcomes using the FACIT-Fatigue scale; - assess the ability of subjects to reduce oral steroids at Day 169; ? evaluate the safety and tolerability of 22 weeks of RSLV-132 exposure; - assess the proportion of subjects achieving a 50% improvement in CLASI activity score - assess the following exploratory endpoints -- evaluate the impact of RSLV-132 treatment on gene expression profile; -- evaluate the impact of RSLV-132 treatment on autoantibody and complement profiles; -- evaluate the impact of RSLV-132 on serum protein levels; -- assess the impact of RSLV-132 on the CLASI damage score

Principal Investigator: Susan Boackle
Protocol #16-0603, No Longer Enrolling: 1/4/2020
Locations: Barbara Davis Center; UCD Barbara Davis Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02660944

A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects with Systemic Lupus Erythematosus (SLE)

-To evaluate the efficacy and dose response of evobrutinib (also referred to as M2951) compared to placebo in reducing disease activity in adult subjects with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard of care (SoC) therapy based on SLE Responder Index (SRI)-4 response at Week 52 in all subjects, or on SRI-6 response at Week 52 in the High Disease Activity (HDA) subgroup, defined as SLE Disease Activity Index 2000 (SLEDAI-2K) !Y 10 -To evaluate the safety of M2951 in subjects with SLE on SoC therapy

Principal Investigator: Susan Boackle
Protocol #17-0405, No Longer Enrolling: 1/6/2021
Locations: Barbara Davis Center; UCD Barbara Davis Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02975336

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis

Protocol #17-1792, No Longer Enrolling: 10/1/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03398837

A randomized, controlled pilot trial to evaluate the efficacy and safety of subcutaneous Abatacept in treating interstitial lung disease associated with the anti-synthetase syndrome

Principal Investigator: Aryeh Fischer
Protocol #17-2000, No Longer Enrolling: 1/6/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03215927

A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS

Principal Investigator: Susan Boackle
Protocol #18-0489, No Longer Enrolling: 1/4/2020
Locations: Barbara Davis Center; UCD Barbara Davis Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03161483

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus

Principal Investigator: Karen Franklin
Protocol #18-0907, No Longer Enrolling: 1/4/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03517722

A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE)

Principal Investigator: Christopher Striebich
Protocol #18-2346, No Longer Enrolling: 9/10/2021
Locations: Outpatient CTRC; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03742037

A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TAK-079 in Combination With Standard Background Therapy in Patients With Moderate to Severe Systemic Lupus Erythematosus

Principal Investigator: Christopher Striebich
Protocol #19-0027, No Longer Enrolling: 9/29/2021
Location: Barbara Davis Center;

More information available at ClinicalTrials.gov: NCT03724916

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy and Safety Study of Methotrexate to Increase Response Rates in Patients with Uncontrolled Gout Receiving Krystexxa (pegloticase)(MIRROR Randomized Controlled Trial [RCT])

Principal Investigator: Christopher Striebich
Protocol #19-1717, No Longer Enrolling: 4/11/2020
Locations: Barbara Davis Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03994731

A Phase 3, Randomized, Double-blind, Placebo and Adalimumab-controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects with Active Psoriatic Arthritis Who Are Naive to Biologic DMARD Therapy

Principal Investigator: Christopher Striebich
Protocol #19-2533, No Longer Enrolling: 5/13/2021
Locations: Barbara Davis Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04115748

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects with Active Psoriatic Arthritis Who Have an Inadequate Response or are Intolerant to Biologic DMARD Therapy

Principal Investigator: Christopher Striebich
Protocol #19-2534, No Longer Enrolling: 5/13/2021
Locations: Barbara Davis Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04115839

GS-US-380-4030: Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching from a Regimen of Dolutegravir and Either Emtricitabine/Tenofovir Alafenamide or Emtricitabine/Tenofovir Disoproxil Fumarate to a Fixed Dose Combination of Bictegravir/ Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Subjects who are Virologically Suppressed

Protocol #17-0713, No Longer Enrolling: 11/14/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03110380

A5320:Viral Hepatitis C Infection Long-term Cohort Study (V-HICS)

Protocol #13-3028, No Longer Enrolling: 10/22/2019
Location: University of Colorado Hospital;

Mitochondria in HIV and Aging (MITO+)

The general hypothesis of the proposed pilot study is that older, HIV-infected individuals with a prolonged antiretroviral therapy (ART) treatment history experience an even greater burden of mitochondrial dysfunction, and resulting symptoms of muscle fatigue, physical function impairment, and impaired exercise tolerance compared to HIV-uninfected controls of a similar age and body mass index (BMI).

Principal Investigator: Kristine Erlandson
Protocol #17-2161, No Longer Enrolling: 7/6/2021
Location: University of Colorado Hospital;

A5366: Selective Estrogen Receptor Modulators to Enhance the Efficacy of Viral Reactivation with Histone Deacetylase Inhibitors

Principal Investigator: Thomas Campbell
Protocol #17-2431, No Longer Enrolling: 4/6/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03382834

An Open-label Study to Assess the Intrapulmonary Concentrations of Cefiderocol at Steady State in Hospitalized Subjects with Bacterial Pneumonia on Treatment with Standard of Care Antibiotics and Requiring Mechanical Ventilation

The study is being performed in patients with bacterial pneumonia, an infection in the lung[s] to determine how safe the experimental drug, cefiderocol, is and the amount of cefiderocol that is in blood and lung secretion over time (also known as pharmacokinetics or PK). All participants in this study will receive the study drug.

Principal Investigator: Jennifer Maitlen
Protocol #18-1706, No Longer Enrolling: 10/13/2020
Location: University of Colorado Hospital;

A5370: Safety and Immunotherapeutic Activity of an Anti-PD-1 Antibody (Cemiplimab) in HIV-1-infected Participants on Suppressive cART: A Phase I/II, Double-blind, Placebo-controlled, Ascending Multiple Dose Study

Scientists are looking for ways to effectively clear HIV-1 that stays in the body despite successful antiretroviral treatment. Anti-PD-1 is a type of antibody that may target certain cells called latently infected cells where HIV hides and may improve the body's ability to clear these cells, allowing for the possibility of reducing the amount of HIV that persists (the HIV reservoir). This study will include participants who are diagnosed with HIV-1 and suppressed on their current antiretroviral medications.

Protocol #18-2675, No Longer Enrolling: 11/2/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03787095

A Pilot Study in the Treatment of Refractory Adenovirus (ADV) Infection with Related Donor ADV Cytotoxic T-Lymphocytes (ADV-CTLs)in Children, Adolescents and Young Adult Recipients - NYMC 579

Principal Investigator: Michael Verneris
Protocol #19-0858, No Longer Enrolling: 3/27/2021
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT03266627

GS-US-200-4334: A Phase 2 Randomized, Open Label, Active Controlled Study Evaluating the Safety and Efficacy of Long-acting Capsid Inhibitor GS-6207 in Combination with Other Antiretroviral Agents in People Living with HIV

This study will test an experimental drug named GS-6207 (long acting capsid inhibitor) in combination with other HIV medications for the treatment of human immunodeficiency virus (HIV) infection. An experimental drug means that it is not yet approved for the treatment of HIV-1 Infection by the United States Food and Drug Administration (FDA) and your country’s regulatory agency. Other HIV medications included in this study are B/F/TAF (Biktarvy?) and, F/TAF (Descovy?), which are currently approved by the U.S. FDA for the treatment of HIV infection and TAF (VEMLIDY?) and Bictegravir (BIC) which are part of the medication Biktarvy but are not currently approved as a single agent HIV medication by the U.S. FDA. This is a randomized, open label study. Open-label means you and your study doctor will know what study drugs you will be taking. Randomized means the study treatment you take will be chosen by chance (like flipping a coin) to receive one of four study treatments. The randomization for this study is in a 2:2:2:1 ratio. You will have 6 out of 7 chances to receive GS-6207 in combination with other HIV medications and a 1 out of 7 chance to receive B/F/TAF.

Principal Investigator: Suzanne Fiorillo
Protocol #19-2810, No Longer Enrolling: 9/26/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04143594

AN ADAPTIVE PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY ASSESSING EFFICACY AND SAFETY OF SARILUMAB FOR HOSPITALIZED PATIENTS WITH COVID-19

Principal Investigator: Suzanne Fiorillo
Protocol #20-0615, No Longer Enrolling: 9/24/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04315298

A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734 ) in Participants with Severe COVID-19 (GS-US-540-5773)

Principal Investigator: Suzanne Fiorillo
Protocol #20-0616, No Longer Enrolling: 1/7/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04292899

ODYSSEY: A randomized, double-blind, placebo-controlled study to investigate the efficacy of in treating inflammatory lung injury and improving clinical outcomes associated with severe COVID-19 infection

Principal Investigator: Jason McCarl
Protocol #20-6037, No Longer Enrolling: 8/13/2021
Locations: Greeley Campus; Long's Peak Hospital; Medical Center of the Rockies; Poudre Valley Hospital;

More information available at ClinicalTrials.gov: NCT04326426

ODYSSEY: A randomized, double-blind, placebo-controlled study to investigate the efficacy of tradipitant in treating inflammatory lung injury and improving clinical outcomes associated with severe COVID-19 infection

The tradipitant therapy is being studied to explore if the administration prevents or treats the cytokine storm and acute respiratory distress syndrome leading to respiratory failure and high mortality in affected patients with COVID-19.

Principal Investigator: Elizabeth Graf
Protocol #20-6506, No Longer Enrolling: 8/12/2021
Locations: Memorial Hospital Central; Memorial Hospital North;

More information available at ClinicalTrials.gov: NCT04326426

A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults to Determine the Safety, Efficacy, and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19

To estimate the efficacy, safety, tolerability and reactogenicity of 2 IM doses of AZD1222 compared to placebo for the prevention of COVID-19 in adults. To see if you qualify for the study, please visit this webpage: http://bit.ly/covid19vaccinestudy

Principal Investigator: Gary Luckasen
Protocol #20-9990, No Longer Enrolling: 2/23/2021
Locations: Greeley Campus; Medical Center of the Rockies; Poudre Valley Hospital;

More information available at ClinicalTrials.gov: NCT04516746

A PHASE 1, OPEN-LABEL DOSE-FINDING STUDY TO EVALUATE SAFETY, TOLERABILITY, AND IMMUNOGENICITY AND PHASE 2/3 PLACEBO-CONTROLLED, OBSERVER-BLINDED SAFETY, TOLERABILITY, AND IMMUNOGENICITY STUDY OF A SARS-COV-2 RNA VACCINE CANDIDATE AGAINST COVID-19 IN HEALTHY CHILDREN ≥5 TO <12 YEARS OF AGE

In this new study, we will learn if the vaccine can produce an immune response against COVID-19, and if it is safe, in children 5-11 years old. All participants will have the opportunity to receive the COVID-19 study vaccine during their time in the trial.

Principal Investigator: Ashleigh Allen
Protocol #21-2841, No Longer Enrolling: 8/18/2021
Location: Childrens Hospital Colorado;

A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients with Chronic Kidney Disease

Assessment of dapagliflozin vs. placebo to slow the progression of kidney disease in patients with chronic kidney disease (CKD). Participation is expected to last between 1.5-4 years with 9-17 visits during that time. Compensation is provided.

Protocol #17-0412, No Longer Enrolling: 10/1/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03036150

Daily Caloric Restriction and Intermittent Fasting in Overweight and Obese Adults with Autosomal Dominant Polycystic Kidney Disease

Principal Investigator: Kristen Nowak
Protocol #17-1327, No Longer Enrolling: 7/8/2021
Locations: Anschutz Health and Wellness; UCD Anschutz Health & Wellness Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03342742

A Randomized Pilot Study of Treatment for Subclinical Antibody-Mediated Rejection in Kidney Transplant Recipients

Protocol #17-1812, No Longer Enrolling: 10/18/2019
Location: University of Colorado Hospital;

A Phase 3 Prospective, Randomized, Multi-Center, Open-Label, Controlled Trial to Assess the Efficacy and Safety of Cellular Immunotherapy with MDR-101 for Induction of Immune Tolerance in Recipients of HLA-Matched, Living Donor Kidney Transplants (the "Study")

MDR-101 is intended to induce mixed lymphohematopoietic chimerism and donor specific immune tolerance in order to preserve transplant kidney function, avert transplant kidney rejection, and eliminate the cumulative and serious side effects associated with IS drugs.Primary Objectives: To evaluate achievement of induction of functional immune tolerance by cellular immunotherapy with MDR-101 in recipients of human leukocyte an tigen (HLA)-matched, living donor kidney transplants. Functional immune tolerance is defined as remaining off of all immunosuppression (IS) drugs for 24 months or more after completion of anti-rejection, IS drug therapy withdrawal with no episodes of biopsy-proven acute rejection (BPAR), de novo donor-specific anti-HLA antibody (dnDSA) development, transplant kidney loss, or subject death. To compare the safety and tolerability of cellular immunotherapy with MDR-101 compared to conventional, standard-of-care (SOC) IS therapy in recipients of HLA-matched, living donor kidney transplants.

Principal Investigator: Alexander Wiseman
Protocol #17-1730, No Longer Enrolling: 6/12/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03363945

A Phase 2, Proof-of-Concept, Randomized, Double-Blinded, Placebo-Controlled Study of ACH-0144471 Treatment for 6 Months in Patients with C3 Glomerulopathy (C3G)

A Phase 2, Proof-of-Concept, Randomized, Double-Blinded, Placebo-Controlled Study of ACH-0144471 Treatment for 6 Months in Patients with C3 Glomerulopathy (C3G)

Principal Investigator: Anna Klochak
Protocol #17-2178, No Longer Enrolling: 5/28/2021
Locations: Childrens Hospital Colorado; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03369236

The Use of Acthar (ACTH) in Patients with Focal Segmental Glomerulosclerosis (FSGS) Who Have Developed Chronic Kidney Disease Stage V (CKD) or End Stage Renal Disease (ESRD) and are Undergoing Renal Transplant

Principal Investigator: Monica Grafals
Protocol #17-2336, No Longer Enrolling: 4/29/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02683889

Acute Kidney Injury and Vascular Function

This is a 12 week observational study of cognitive and blood vessel functioning 2 weeks and 12 weeks after an acute kidney injury.

Principal Investigator: Anna Jovanovich
Protocol #18-0654, No Longer Enrolling: 4/6/2021
Location: University of Colorado Hospital;

A Multicenter, Prospective, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study of ANG-3777 (formerly BB3) to Reduce the Severity of Delayed Graft Function in Recipients of a Deceased Donor Kidney

The study is a multicenter, prospective, double-blind, randomized, placebo-controlled, pivotal registration study. The Sponsor, Investigators and patients will all be blinded to study drug assignment. Patients in this study are at risk for requiring dialysis in the first week following transplantation of a kidney from a deceased donor and have early clinical indication of DGF based on poor renal function post-transplantation. Patients who fulfill all other eligibility criteria will be randomized in a 1:1 fashion to receive 2 mg/kg ANG-3777 or placebo (normal saline).Primary Objective: ? To demonstrate the safety and efficacy of ANG-3777 in reducing the severity of delayed graft function (DGF) in recipients at high risk of DGF after receiving a deceased donor renal allograft with DGF Secondary Objectives: ? To demonstrate the efficacy of ANG-3777 in optimizing renal function in recipients of a deceased donor renal allograft with DGF ? To demonstrate the efficacy of ANG-3777 in reducing length of hospital stay in recipients of a deceased donor renal allograft with DGF

Principal Investigator: James Cooper
Protocol #16-1038, No Longer Enrolling: 10/2/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02474667

A randomized double-blind placebo-controlled study to evaluate the efficacy and safety of CINRYZE? (C1 esterase inhibitor [human]) for the treatment of acute antibody-mediated rejection in kidney transplant patients 22Nov2017

Protocol #17-0275, No Longer Enrolling: 10/1/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02547220

Multicenter, randomized, double-blind, placebo-controlled two stage study to characterize the efficacy, safety, tolerability and pharmacokinetics of GZ/SAR402671 in patients at risk of rapidly progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)

This is an international, multicenter trial. Participants will be given either active study drug or placebo and will be followed for a period of 2 years.

Principal Investigator: Beverly Farmer
Protocol #18-1842, No Longer Enrolling: 9/22/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03523728

A 12 month, partially-blinded, active-controlled, multicenter, randomized study evaluating efficacy, safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) of an anti-CD40 monoclonal antibody, CFZ533, in de novo and maintenance kidney transplant recipients (CIRRUS I)

Study CCFZ533A2201 is a randomized, 12-month, active-controlled, partially-blinded, multicenter, dose range finding study to evaluate the efficacy, safety, tolerability, PK and PD of CFZ533 in 2 different cohorts: -In adult de novo kidney transplant recipients, CFZ533 in combination with MMF and corticosteroids as compared to standard of care comprised of tacrolimus, MMF and corticosteroids. -In a maintenance kidney transplant population (6-24 months post-transplant), CFZ533 in combination with MMF with or without corticosteroids, compared to a standard of care control arm of tacrolimus and MMF with or without corticosteroids. COHORT 1: Primary Objective(s) -To demonstrate that CFZ533 600 mg or 300 mg bi-weekly (Q2W), subcutaneous (SC), are non-inferior to a tacrolimus-based regimen with respect to the proportion of patients who experience the composite efficacy failure event (Biopsy proven acute rejection (BPAR), Graft Loss or Death) over 12 months post-transplantation. Key secondary objective: -To demonstrate that CFZ533 600 mg or 300 mg Q2W SC are superior to a tacrolimus-based regimen with respect to the mean estimated glomerular filtration rate (eGFR) at 12 months post-transplantation. COHORT 2: Primary Objective(s) -To demonstrate that CFZ533 450 mg Q2W SC is non-inferior to a tacrolimus-based regimen with respect to the proportion of patients who experience the composite event (BPAR, Graft Loss or Death) over 12 months post conversion. Key secondary objective: -To demonstrate that CFZ533 450 mg Q2W SC is superior to a tacrolimus-based regimen with respect to the mean change in eGFR from baseline to 12 months post conversion.

Principal Investigator: Alexander Wiseman
Protocol #18-2117, No Longer Enrolling: 6/12/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03663335

A randomized, controlled, multi-center, safety and efficacy study of FCR001 cell-based therapy relative to a tacrolimus and mycophenolate-based regimen in de novo living donor renal transplant recipients, and safety in FCR001 donors (the FREEDOM-1 study)

Evaluation of safety, efficacy and immunosuppression (IS) therapy following FCR001 cell therapy after kidney transplant vs. standard of care. FCR001 is a novel, cryopreserved allogeneic somatic cell therapy, derived from mobilized peripheral blood mononuclear cells from the same donor as the allograft, and containing hematopoietic progenitor cells, facilitating cells and alpha beta T cells. The rationale is to establish durable chimerism and donor-specific tolerance in the recipient enabling freedom from chronic IS and its associated toxicities.Primary Objective: To evaluate the proportion of FCR001 recipients who are free from IS, without biopsy-proven acute rejection (BPAR), at 24 months posttransplant. Key Secondary Objective: To evaluate the change in renal function (estimated glomerular filtration rate [eGFR] by Modification of Diet in Renal Disease (MDRD4) from post-transplant baseline (Month 1) to Month 24 in FCR001 recipients.

Principal Investigator: Alexander Wiseman
Protocol #19-1299, No Longer Enrolling: 9/30/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03995901

Kidney Immunosuppression Dosed Daily Only (KIDDO)

Principal Investigator: Anna Klochak
Protocol #17-2311, No Longer Enrolling: 10/21/2020
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT04156204

X-linked Hypophosphatemia Disease Monitoring Program (XLH-DMP)

Principal Investigator: Bradley Dixon
Protocol #18-0225, No Longer Enrolling: 3/26/2020
Location: Childrens Hospital Colorado;

A Phase 3 Multicenter, Randomized, Double-Blinded, Placebo-Controlled Withdrawal Study Evaluating ADV7103 in Pediatric and Adult Subjects with Distal Renal Tubular Acidosis

Principal Investigator: Anna Klochak
Protocol #18-2100, No Longer Enrolling: 8/1/2020
Location: Childrens Hospital Colorado;

A Randomized, Multicenter, Double-Blind, Parallel, Active-Control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) (DUPLEX Study)

Principal Investigator: Anna Klochak
Protocol #17-2378, No Longer Enrolling: 2/20/2021
Location: Childrens Hospital Colorado;

A Phase 2 Study to Evaluate the Safety and Biologic Activity of APL-2 in Patients With IgA Nephropathy, Lupus Nephritis, Primary Membranous Nephropathy, or C3 Glomerulopathy (C3 Glomerulonephritis and Dense Deposit Disease)

Principal Investigator: Anna Klochak
Protocol #18-1723, No Longer Enrolling: 6/24/2020
Location: Childrens Hospital Colorado;

An adaptive seamless randomized, double-blind, placebocontrolled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients

Each study subject will be randomized to receive either study drug or a placebo for 6 months. Neither the subject nor the study staff will know which treatment was given until after the study has finished. Study subjects will be monitored every 2 weeks for the first month, then less frequently as the study progresses. The total length of the study is about 8 months.

Principal Investigator: Judith Blaine
Protocol #19-2819, No Longer Enrolling: 9/25/2020
Locations: Renal Research Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03373461

A PHASE 3, OPEN-LABEL, MULTICENTER STUDY OF ALXN1210 IN CHILDREN AND ADOLESCENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME (aHUS)

Principal Investigator: Anna Klochak
Protocol #17-0573, No Longer Enrolling: 6/4/2021
Location: Childrens Hospital Colorado;

A Phase 3, Prospective, Open-Label, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Paricalcitol Oral Solution for the Treatment of Secondary Hyperparathyroidism in Pediatric Subjects Ages 0 to 9 Years with Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis

Principal Investigator: Anna Klochak
Protocol #19-2333, No Longer Enrolling: 2/9/2021
Location: Childrens Hospital Colorado;

A Phase 2, Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of BMS-986165 with Background Treatment in Subjects with Lupus Nephritis

Each study subject will start with 12 weeks of treatment of MMF. After the 12 weeks of MMF, the subjects with an inadequate renal response may be randomized to one of the BMS-986165 treatment groups or placebo as add-on treatment to MMF. Subjects will be monitored and evaluated every 4 weeks for 52 weeks. Neither the subject or study staff will know which treatment was given until after the study has finished.

Principal Investigator: Joshua Thurman
Protocol #19-2904, No Longer Enrolling: 7/13/2021
Locations: Renal Research Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03943147

Setmelanotide (RM-493) Phase 2 Treatment Trial in Patients with rare genetic disorders of obesity

Principal Investigator: Jeanne Anne Breen
Protocol #17-0373, No Longer Enrolling: 6/24/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03013543

Neural Effects of Negative Affect on Food Choices and Reward Processing In Individuals with Binge Eating Episodes

The goal of this study is to learn more about how brain function drives binge eating, a condition where individuals eat unhealthy large amounts of food

Protocol #16-2658, No Longer Enrolling: 10/1/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03393039

Pilot study of time restricted feeding as a weight loss intervention in overweight and obese adults

Principal Investigator: Elizabeth Thomas
Protocol #18-0487, No Longer Enrolling: 2/27/2020
Locations: Anschutz Health and Wellness; UCD Anschutz Health & Wellness Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03571048

A Phase 2a, Randomized, Open-Label, Active Control, Multi- Center Study to Assess the Efficacy and Safety of ASKP1240 in de novo Kidney Transplant Recipients

The primary objectives of this study are: - to compare the efficacy of basiliximab induction, ASKP1240, mycophenolate mofetil [MMF], and steroids to the standard of care immunosuppressive regimen (basiliximab induction + tacrolimus + MMF + steroids) [CNI avoidance]. - to compare the efficacy of basiliximab induction, ASKP1240, tacrolimus, and steroids to the standard of care immunosuppressive regimen (basiliximab induction + tacrolimus + MMF + steroids) [CNI minimization- MMF avoidance]. The secondary objectives of this study are: - to compare the safety of the experimental arms to the standard of care arm. -to evaluate the long term safety and tolerability of ASKP1240 administration in subjects in the Long Term Extension (LTE) period of the study.

Protocol #13-0061, No Longer Enrolling: 10/1/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT01780844

Helping Ourselves, Helping Others: The Young Women's Breast Cancer Study

This study plans to learn more about breast cancer in young women, including the biology of the disease and young women's experiences with it. We aim to use this information to improve the care and information available for young women with breast cancer.

Principal Investigator: Virginia Borges
Protocol #08-1222, No Longer Enrolling: 2/12/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT01468246

Quantification of Pain Sensitivity to Controlled Objective Pain Stimuli

Principal Investigator: Claire Cofer
Protocol #07-0354, No Longer Enrolling: 2/13/2021
;

Inter-Segmental Coordination and Ankle-foot Orthoses during Gait by Children with Spastic Cerebral Palsy

Principal Investigator: David Robertson
Protocol #10-1084, No Longer Enrolling: 10/2/2021
;

The Chest Wall And Spine Deformity Registry

Protocol #11-1248, No Longer Enrolling: 10/24/2019
;

REAL Athlete Injury Tracking Database

Principal Investigator: Ada Sochanska
Protocol #11-1640, No Longer Enrolling: 6/30/2021
;

Autograft plus Allograft Hybrid ACL Reconstruction

Principal Investigator: Cyndi Long
Protocol #12-0144, No Longer Enrolling: 1/6/2021
;

Health Related Quality of Life and Surgical Outcomes of Patients Attending Amputee and Deformity Clinic (Amputee Database)

Protocol #12-1525, No Longer Enrolling: 11/1/2019
;

Chronic Recurrent Multifocal Osteomyelitis (CRMO): Functional Outcomes and Quality of Life in Patients Undergoing Treatment

Protocol #12-1557, No Longer Enrolling: 11/1/2019
;

Multicenter Prospective Cohort Study on Current Treatments of Legg-Calve-Perthes Disease

Protocol #13-0101, No Longer Enrolling: 11/1/2019
;

The Use of Casting in Patients with Infantile Scoliosis

Protocol #13-2952, No Longer Enrolling: 10/24/2019
;

Quantification of the variable expression of estrogen receptors in human articular cartilage of healthy versus osteoarthritic females

Principal Investigator: Evalina Burger-Van der Walt
Protocol #14-1971, No Longer Enrolling: 1/6/2021
;

Impact of Neck Strengthening Program in Adolescent Athletes

Principal Investigator: Ada Sochanska
Protocol #14-0712, No Longer Enrolling: 6/30/2021
;

Analysis of prognostic cell signaling factors in Adolescent Idiopathic Scoliosis

Protocol #14-0884, No Longer Enrolling: 10/24/2019
;

Women with Cancer Survivorship Outcomes Program (WCSOP)

Principal Investigator: Alyse Brennecke
Protocol #15-1397, No Longer Enrolling: 11/23/2019
Location: University of Colorado Hospital;

Biobank Protocol to Store Specimens and Data on Eligible Subjects that Consented to COMIRB Protocol 13-1744

Protocol #15-1676, No Longer Enrolling: 10/22/2019
;

Retrospective Review of Minimally Invasive Placement of Pedicle Screws in Spine Surgery

Principal Investigator: Christopher Kleck
Protocol #14-0654, No Longer Enrolling: 10/2/2021
;

15-1621 A Phase 0 Trial of Gemcitabine in Newly-Diagnosed Diffuse Intrinsic Pontine Glioma

Principal Investigator: Adam Green
Protocol #15-1621, No Longer Enrolling: 3/10/2020
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT02992015

Safety and Efficacy of Pulsed Electromagnetic Fields (Cervical-Stim?) as an Adjunct to Enhance Union in Conservatively Treated Type II Fractures of the Odontoid Process

Principal Investigator: Vikas Patel
Protocol #14-2369, No Longer Enrolling: 11/3/2021
;

15-2069 Using the Neurologic Assessment in Neuro-oncology (NANO) Scale as a Predictive Assessment Tool for Survival in Malignant Glioma

Protocol #15-2069, No Longer Enrolling: 10/1/2019
Location: University of Colorado Hospital;

A221405 POSITIVE (Pregnancy Outcome and Safety of Interrupting Therapy for women with endocrine responsive breast cancer)

Principal Investigator: Gwendolyn Wade
Protocol #15-2078, No Longer Enrolling: 1/17/2020
Locations: Greeley Hospital; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02308085

Review of Outcomes of Bone Marrow Transplant (BMT) Patients

Principal Investigator: Michael Verneris
Protocol #15-2279, No Longer Enrolling: 11/28/2019
;

Functional Connectivity of the Basal Ganglia in Primary Focal Dystonia

In this study we are looking at how the brain works in people who have dystonia compared to those who don't have dystonia. This study will use magnetic resonance imaging (MRI), magnetoencephalography (MEG), and Electroencephalography (EEG) to see how the brain reacts while resting and doing a finger-tapping task. Aim 1: A second level contrast between Primary Focal Dystonia (PFD) and Healthy Controls (HC) of the statistical parametric maps of correlation coefficients at rest and during a tapping motor task Aim 2: the strength of correlation between basal ganglia motor network functional connectivity measures and total PFD clinical assessment scale scores

Principal Investigator: Brian Berman
Protocol #12-0289, No Longer Enrolling: 2/4/2021
Locations: Colorado Research Center; Department Specific Free Standing Clinic; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT01761903

15-0963 Analysis of Biofluid Extracellular Vesicles from Brain Tumor Patients

Protocol #15-0963, No Longer Enrolling: 10/22/2019
;

G1T28 Biobanking

Protocol #15-1187, No Longer Enrolling: 10/22/2019
;

Comparative Analysis of Intraosseous and Soft Tissue Meningiomas

Protocol #15-1106, No Longer Enrolling: 10/22/2019
;

Retrospective Analysis of "Second-Look" (Re-Staging) Transurethral Resection on the Development of Bladder Cancer and the Difference in Cost of Care for Patients with and without Second Look Resection

Protocol #16-1023, No Longer Enrolling: 11/7/2019
Location: University of Colorado Hospital;

I3Y-MC-JPCE Phase 1b Study of Abemaciclib in Combination with Pembrolizumab for Patients with Stage IV Non-Small Cell Lung Cancer or Hormone Receptor Positive, HER2 Negative Breast Cancer

Principal Investigator: Gwendolyn Wade
Protocol #16-0705, No Longer Enrolling: 9/22/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02779751

An Intermediate-size, Expanded Access Protocol to Provide Brincidofovir for the Treatment of Serious Adenovirus Infection or Disease (PROTOCOL No. CMX001-351)

Principal Investigator: Roger Giller
Protocol #16-0225, No Longer Enrolling: 6/29/2021
;

More information available at ClinicalTrials.gov: NCT02596997

Successful use of EPOCH-R in two pediatric patients with Burkitts Lymphoma and Acute Kidney Injury: a case report

Principal Investigator: KELLY MALONEY
Protocol #16-0907, No Longer Enrolling: 11/23/2019
Location: Childrens Hospital Colorado;

A Pilot Clinical Trial of Genomic Based Assignment of Therapy in Advanced Urothelial Carcinoma

Protocol #16-1082, No Longer Enrolling: 10/18/2019
Location: University of Colorado Hospital;

Patient-Initiated Biobanking of Deceased Lung Cancer Patient Tissues

To collect archival tissues and validated clinical history of deceased Lung cancer patients & deposit them into the NCI SPORE biobank

Principal Investigator: DANIEL MERRICK
Protocol #15-1294, No Longer Enrolling: 11/23/2019
Locations: Department Specific Free Standing Clinic; University of Colorado Cancer Center;

AOST1421 A Phase II Study of Human-Mouse Chimeric Anti-Disialoganglioside Monoclonal Antibody ch14.18 (Dinutuximab, NSC#764038, IND#4308) in Combination with GM-CSF in Patients with Recurrent Osteosarcoma

Principal Investigator: Tim Garrington
Protocol #15-2393, No Longer Enrolling: 5/22/2020
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT02484443

Apollo Onyx Delivery Micro Catheter Post Market Safety Study

Protocol #14-2270, No Longer Enrolling: 10/1/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02378883

BIPM Biorepository Project (BBP)/ Rocky Mountain Biorepository (RMB)

Protocol #15-0461, No Longer Enrolling: 11/9/2019
Locations: Boulder Health Center; Cherry Creek Medical Center; Greeley Hospital; Harmony Campus; Lone Tree Medical Center; Longs Peak Hospital; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital; Poudre Valley Hospital; Steadman Hawkins Clinic - Denver; UCHealth Internal Medical Clinic - Lowry; UCHealth Stapleton Medical Center; University of Colorado Hospital;

Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations

1. To determine which pharmaceutical therapy is most effective and causes the fewest side effects in CSPN. 2. To determine which drug has the fewest and which has the most side effects.

Protocol #14-2157, No Longer Enrolling: 10/1/2019
Location: University of Colorado Hospital;

The Impact of Vocal Folds Augmentation with Injection Laryngoplasty on Quality of Voice in Patients with Parkinson Disease (VoCAL-PD ? Vocal Cords Augmentation Laryngoplasty in PD)

1. To assess the effect of vocal folds augmentation with long acting calcium hydroxyapatite paste on the quality of voice in PD subjects. 2. To assess the effect of vocal folds augmentation with long acting calcium hydroxyapatite paste on structural and functional parameters of the larynx measured on videostroboscopic recordings assessing glottic closure time and supraglottic constriction. 3. Assess the duration of the long term treatment effect.

Principal Investigator: Maureen Leehey
Protocol #16-1127, No Longer Enrolling: 5/11/2021
Location: University of Colorado Hospital;

ADVL1412 A Phase 1/2 Study of Nivolumab (IND#124729) in Children, Adolescents, and Young Adults with Recurrent or Refractory Solid Tumors as a Single Agent and in Combination with Ipilimumab

Principal Investigator: Carmen Rivera
Protocol #16-1285, No Longer Enrolling: 4/15/2020
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT02304458

RANDOMIZED PHASE III TRIAL EVALUATING THE ROLE OF WEIGHT LOSS IN ADJUVANT TREATMENT OF OVERWEIGHT AND OBESE WOMEN WITH EARLY BREAST CANCER

Principal Investigator: Anthony Elias
Protocol #16-1240, No Longer Enrolling: 3/10/2021
Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02750826

WHOLE BLOOD SPECIMEN COLLECTION FROM PREGNANT SUBJECTS (PRO-101-SAMPLES)

To obtain whole blood specimens from pregnant subjects to be used for research and development and clinical validation studies of prenatal assays.

Principal Investigator: Chloe Banel
Protocol #16-0911, No Longer Enrolling: 1/21/2021
Locations: Childrens Hospital Colorado; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02430584

Tumor Genetics as Predictors of Response to Stereotactic Radiosurgery (SRS) in Melanoma Brain Metastases

Principal Investigator: D. Ryan Ormond
Protocol #16-0908, No Longer Enrolling: 11/23/2019
Location: University of Colorado Hospital;

Effects of Antidepressant Medication Use in Glioblastoma Multiforme

Principal Investigator: D. Ryan Ormond
Protocol #16-0895, No Longer Enrolling: 11/23/2019
Location: University of Colorado Hospital;

NANT 2015-01: Neuroblastoma Precision Trial

Principal Investigator: Deb Schissel
Protocol #16-0932, No Longer Enrolling: 11/19/2020
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT02868268

Evaluation of Colorado Oncology Providers on the Use of Medical Marijuana

Protocol #16-1541, No Longer Enrolling: 11/20/2019
Location: University of Colorado Hospital;

Malglycemia in the Pediatric Hematopoietic Stem Cell Transplant Population

Principal Investigator: Jenna Sopfe
Protocol #16-1496, No Longer Enrolling: 11/23/2019
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT03482154

Mediators of Perceived Exercise Effort in Type 2 Diabetes - Barriers to Physical Activity

Principal Investigator: Amy Huebschmann
Protocol #11-0909, No Longer Enrolling: 7/6/2021
;

When is enough, enough? Investigating end-of-life care provided to HSCT recipients

Principal Investigator: Elissa Kolva
Protocol #16-1714, No Longer Enrolling: 11/23/2019
Location: University of Colorado Hospital;

Bromocriptine QR as adjunct therapy in Type 1 Diabetes

Principal Investigator: Ellen Lyon
Protocol #15-1309, No Longer Enrolling: 12/27/2019
Locations: CTRC-adult; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02544321

A prospective, single blinded, multi-center, randomized, controlled, pivotal study to assess the safety and effectiveness of the InSpace device for treatment of full thickness Massive Rotator Cuff Tears

Protocol #15-1348, No Longer Enrolling: 10/1/2019
;

More information available at ClinicalTrials.gov: NCT02208440

Skin cancer prevention in a young adult population - nevus excision

Principal Investigator: Darren Lynn
Protocol #16-1782, No Longer Enrolling: 10/8/2020
Location: University of Colorado Hospital;

Comparison of Prolaris and Oncotype Dx Genomic Prostate Cancer Tests

Principal Investigator: E. David Crawford
Protocol #16-2525, No Longer Enrolling: 11/23/2019
Location: University of Colorado Hospital;

Prostate Cancer and Prospect of Brain Metastases Development

Protocol #16-1884, No Longer Enrolling: 10/22/2019
Location: University of Colorado Hospital;

Genomics and Proteomics of Chemosensitivity in Bladder Cancer

Protocol #16-1983, No Longer Enrolling: 10/22/2019
Location: University of Colorado Hospital;

Effect of Metformin on Vascular and Mitochondrial Function in Type 1 Diabetes

Principal Investigator: Ellen Lyon
Protocol #11-0693, No Longer Enrolling: 12/27/2019
Locations: CTRC-adult; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT01813929

Role of vascular function: oxygen delivery vs oxygen utilization in the exercise impairment in type 2 diabetes

Protocol #06-0062, No Longer Enrolling: 10/1/2019
Locations: CTRC-adult; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT01793909

Impact of sitagliptin on cardiovascular exercise performance in type 2 diabetes

Protocol #13-2015, No Longer Enrolling: 10/4/2019
Location: CTRC-adult;

More information available at ClinicalTrials.gov: NCT01951339

The Oncoshare Project: An integrated informatics approach to understanding breast cancer survival.

Principal Investigator: Anosheh Afghahi
Protocol #16-2276, No Longer Enrolling: 11/23/2019
;

Molecular Analysis of Drug Sensitivity and Resistance in Advanced Thyroid Cancer

Principal Investigator: Bryan Haugen
Protocol #16-0868, No Longer Enrolling: 11/23/2019
Location: University of Colorado Hospital;

A011502: A RANDOMIZED PHASE III DOUBLE BLINDED PLACEBO CONTROLLED TRIAL OF ASPIRIN AS ADJUVANT THERAPY FOR HER2 NEGATIVE BREAST CANCER: THE ABC TRIAL

Principal Investigator: Gwendolyn Wade
Protocol #16-2437, No Longer Enrolling: 12/5/2020
Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02927249

Multicenter, Open-Label, Phase 3 Study of Tabelecleucel for Allogeneic Hematopoietic Cell Transplant Subjects with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease after Failure of Rituximab (MATCH Study)

Principal Investigator: Elizabeth Chick
Protocol #16-2448, No Longer Enrolling: 9/30/2020
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT03392142

Colorectal Cancer Incidence Trends in Colorado

Protocol #16-2487, No Longer Enrolling: 10/24/2019
Location: University of Colorado Hospital;

S1418/BR006, A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with greater than 1 cm Residual Invasive Cancer or Positive Lymph Nodes (greater than pN1mic) After Neoadjuvant Chemotherapy.

Principal Investigator: Anthony Elias
Protocol #16-2594, No Longer Enrolling: 8/19/2021
Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02954874

Automated Three Dimensional Morphologic Analysis of Sputum Cells for the Diagnosis of Lung Cancer

Principal Investigator: MARY JACKSON
Protocol #16-2160, No Longer Enrolling: 11/23/2019
Locations: Rocky Mountain Regional VA Medical Center; University of Colorado Hospital;

Survey of Protocol Review and Monitoring Systems in U.S. Cancer Centers

Protocol #16-2755, No Longer Enrolling: 10/22/2019
Location: University of Colorado Hospital;

a characterization of the effect of total knee arthroplasty on glycemic control in the VA population

Protocol #15-2242, No Longer Enrolling: 1/15/2021
;

a retrospective review of regional variation in pediatric musculoskeletal infection

Protocol #15-2466, No Longer Enrolling: 3/10/2021
;

BIOMARKERS IN BARRETT'S ESOPHAGUS AND ESOPHAGEAL ADENOCARCINOMA: THE TREAT-BE (TREATMENT WITH RESECTION AND ENDOSCOPIC ABLATION TECHNIQUES FOR BARRETT'S ESOPHAGUS) CONSORTIUM BIOBANK

Principal Investigator: SACHIN WANI
Protocol #16-2636, No Longer Enrolling: 11/26/2019
Location: University of Colorado Hospital;

A Review of the Incidence of CNS Metastasis in Prostate Cancer and Possible Pharmaceutical Links to Increasing Occurrence

Protocol #17-0192, No Longer Enrolling: 10/1/2019
Location: University of Colorado Hospital;

STRENGTH: Seeking To Reactivate Esophageal aNd Gastric Treatment Health

Principal Investigator: ASHLEY GLODE
Protocol #16-2228, No Longer Enrolling: 11/26/2019
Location: University of Colorado Hospital;

Mood and Excess Weight Gain in Adolescent Pregnancy

Protocol #14-1505, No Longer Enrolling: 10/4/2019
Location: University of Colorado Hospital;

Factors mediating gut microbiota dysbiosis and metabolic disease in HIV patients.

This study plans to learn more about immune responses in intestinal (gut) tissue in people with human immunodeficiency virus (HIV) infection. This study will determine whether change in the composition of gut bacteria in HIV infected individuals is related to a high prevalence of chronic gut inflammation and metabolic disease. The investigators will also investigate immune-modulatory properties of specific bacteria that correlate with disease both by characterizing which functional genes are selected for in their genomes and by stimulating immune cells isolated from blood and gut tissue with bacterial isolates. This work will establish whether gain/loss of bacterial drivers/suppressors of information in the gut contributes to metabolic disease in HIV-infected individuals.

Protocol #14-1595, No Longer Enrolling: 10/4/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02258685

Effect of Interferon gamma 1-b (IFN-gamma 1b) on Innate Immune Cells

The investigators hypothesize that neutrophils and monocytes developed under the influence of Interferon- gamma-1b (IFN-gamma-1b, Actimmune(R) in vivo will display enhanced function across a broad range of activities related in large part to the transcriptional activation effects of this cytokine. The investigators will evaluate the effects of IFN-? in healthy human subjects in vivo on gene expression, biologic activity markers, and functional activity of myeloid cells in single dose studies and in steady state studies.

Protocol #15-1643, No Longer Enrolling: 10/1/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02609932

CD8+ T-cell Responses to a Conserved Herpesvirus Epitope After Natural Infection, Vaccination, or Reactivation with Human Herpesviruses

Principal Investigator: Myron Levin
Protocol #13-2122, No Longer Enrolling: 4/6/2021
Location: University of Colorado Hospital;

Exercise for Healthy Aging

The primary objective of this proposal is to compare a moderate or high intensity exercise intervention to improve physical function in persons aging with Human Immunodeficiency Virus (HIV).

Protocol #14-2207, No Longer Enrolling: 10/4/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02404792

IMPAACT 2012: Phase I Placebo-Controlled Study of the Infectivity, Safety and Immunogenicity of a Single Dose of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, LID cp AM2-2, Lot RSV#009B, Delivered as Nose Drops to RSV-Seronegative Infants 6 to 24 Months of Age, Version 1.0

Principal Investigator: Elizabeth Mcfarland
Protocol #16-1564, No Longer Enrolling: 12/17/2019
;

PTH And Calcium Responses to Exercise (PACE) in Older Adults

The primary goal of this research is to find out if exercise that causes the loss of calcium from the blood, possibly through the sweat, also causes the release of calcium from the bones.

Principal Investigator: Sarah Wherry
Protocol #15-0250, No Longer Enrolling: 5/20/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02468817

Female Influences on the Etiology of Rheumatoid Arthritis (FIERA) Study

1. To establish the relationship between exposure to certain female factors (e.g. contraceptive, menstrual, pregnancy and sexual history) and the presence of serum RA-related autoimmunity and/or RA-related immunologic factors in subjects with RA, subjects at-risk for RA, and control subjects. These evaluations will include baseline and longitudinal studies to determine incident development of RA-related autoimmunity. 2. To determine the prevalence of RA-related biomarkers, such as Abs and inflammatory cytokines, in the lower female genital tract in women with RA, women at-risk for RA, and controls. These evaluations will include baseline and longitudinal studies to determine incident development of RA-related autoimmunity at the CV mucosa. 3. To evaluate microbial communities in the lower female genital tract of women with RA, women at-risk for RA, and control subjects. These evaluations will include baseline and longitudinal studies of microbiota as well as comparison to serum and CV biomarkers. 4. To simultaneously compare RA-related Abs and immunologic biomarkers in the female genital tract and serum in women with RA, women at-risk for RA and control subjects. These evaluations include cross-sectional and longitudinal studies to determine evolution over time at each site (CV fluid and serum) to determine incident development of RA-related autoimmunity. 5. To demonstrate specific immunologic mechanisms of RA-related Ab generation in the cervical and uterine mucosa associated with systemic or mucosal RA-related Abs in women who had previously obtained and stored cervical or uterine tissue. 6. To compare the performance of self-collected and investigator-collected CV samples for detection of mucosal immunity and microbiota.

Protocol #14-1751, No Longer Enrolling: 10/4/2019
Location: University of Colorado Hospital;

Bioequivalence of tenofovir and emtricitabine following over-encapsulation

The goal of this study is to determine whether the use of the PSS with Truvada will vary the drug concentrations of FTC/TDF.

Protocol #16-1478, No Longer Enrolling: 10/16/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02968576

Feasibility Study of Metformin Therapy in ADPKD V: 6.20.2017

The primary purpose of the research study is to determine the safety and tolerability of the study drug (Metformin or placebo) when given to subjects with ADPKD (Autosomal Dominant Polycystic Kidney Disease).

Principal Investigator: Diana George
Protocol #16-0802, No Longer Enrolling: 7/6/2021
Locations: Department Specific Free Standing Clinic; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02903511

EFFECTS OF SERUM FATTY ACID LOWERING ON INSULIN SENSITIVITY, CARDIOVASCULAR FUNCTION, AND EXERCISE CAPACITY IN NON-INSULIN DEPENDENT DIABETES

To research the effects of an investigational drug on exercise capacity and blood vessel function​.​

Principal Investigator: Ellen Lyon
Protocol #10-1393, No Longer Enrolling: 5/18/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT01580813

Effectiveness Analysis of Natalizumab versus Fingolimod using Patient-Reported Outcomes in Patients with Multiple Sclerosis

The purpose of this study is to compare two medications, natalizumab and fingolimod, used in the treatment of multiple sclerosis (MS) through a variety of previously validated patient reported outcomes (PROs).

Principal Investigator: Kavita Nair
Protocol #13-2767, No Longer Enrolling: 7/6/2021
Location: University of Colorado Hospital;

Qualitative Needs Assessment for a Hospice Care Decision Aid

Principal Investigator: Channing Tate
Protocol #16-0479, No Longer Enrolling: 10/2/2021
Locations: Denver Health and Hospital Authority; University of Colorado Hospital;

Pilot Study to Examine the Impact of Overfeeding on Peripheral Clock Gene Expression in Humans

The overall goal of this pilot project is to take the first steps toward developing translational methods to investigate links between changes in energy flux and the circadian system in human tissues.

Principal Investigator: Corey Rynders
Protocol #15-1570, No Longer Enrolling: 12/27/2019
Locations: CTRC-adult; Denver Health Medical Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02809482

Insular Inhibitory Neuromodulation to Reduce Cigarette Craving and Alter Brain Function in Smokers

The goal of this study is to determine if a specific experimental brain stimulation technique can be used as a non-invasive way to reduce cigarette cravings in current smokers.

Principal Investigator: Michael Regner
Protocol #15-1016, No Longer Enrolling: 6/30/2021
;

More information available at ClinicalTrials.gov: NCT02590640

Heart Sounds at Home: Prospective Maternal Surveillance of SSA Positive Pregnancies Using a Hand-Held Fetal Heart Rate Monitor

The purpose of the research study "Heart Sounds at Home" is for pregnant SSA or SSA/SSB (Sjogren syndrome B) antibody positive mothers to use a Doppler fetal heart rate monitor to detect abnormal heart rates and rhythms in their babies before they are born.

Principal Investigator: Bettina Cuneo
Protocol #13-1879, No Longer Enrolling: 5/1/2021
;

More information available at ClinicalTrials.gov: NCT02920346

Eosinophils and Gastrointestinal Inflammation

Determine the efficacy of the EnteroTracker String Test (EST)for monitoring inflammation in the esophagus. Compare analysis of the EST to biopises taken during an upper endoscopy.

Principal Investigator: Faria Ahmed
Protocol #07-0223, No Longer Enrolling: 12/31/2019
Locations: Childrens Hospital Colorado; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02008903

A phase III, open label, multicenter study to evaluate the impact of reactogenicity on Quality of Life (QoL), after intramuscular administration of GSK Biologicals candidate Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A) in adults > or = 50 years of age

Principal Investigator: Myron Levin
Protocol #16-1787, No Longer Enrolling: 6/30/2021
;

Effectiveness of Therapy via Telemedicine following Cochlear Implants

This research plans to learn more about the use of telemedicine as a means of providing therapy to children who have a cochlear implant(s). While Auditory-Verbal Therapy has typically been delivered in person, many people are starting to access therapy over the internet. We are conducting this research to determine if the outcomes of therapy are the same when AVT is delivered in person and via telemedicine.

Principal Investigator: JAMES GRIGSBY
Protocol #12-1103, No Longer Enrolling: 9/21/2021
;

Phosphate Lowering to Treat Vascular Dysfunction in Chronic Kidney Disease

Principal Investigator: Anna Jovanovich
Protocol #13-0328, No Longer Enrolling: 10/2/2021
;

More information available at ClinicalTrials.gov: NCT02209636

Mechanisms of Vascular Dysfunction in CKD and ADPKD: A Cross-Sectional Study

This research study will compare blood vessel function in healthy adults to adults with two different types of kidney disease. The testing visit will include non-invasive testing of blood vessel function and collection of blood and cells from an IV.

Principal Investigator: Kristen Nowak
Protocol #15-0869, No Longer Enrolling: 7/6/2021
;

Inotuzumab Ozogamicin Compassionate Access Single IND

Principal Investigator: Deirdre Appelhans
Protocol #16-2747, No Longer Enrolling: 3/10/2020
Location: Childrens Hospital Colorado;

ALTE1621 Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Heart Failure (PREVENT-HF): A Phase 2b Randomized Placebo-Controlled (Carvedilol) Trial

Principal Investigator: Barb Shepperd
Protocol #17-0486, No Longer Enrolling: 1/22/2021
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT02717507

Twenty-One-Gene Recurrence Score Assay in CHEK2-Associated Versus Sporadic Breast Cancers: A Case-Control Study

Principal Investigator: Anosheh Afghahi
Protocol #17-0763, No Longer Enrolling: 11/26/2019
Location: University of Colorado Hospital;

Rituximab plus Cyclophosphamide followed by Belimumab For the Treatment of Lupus Nephritis

Protocol #16-0604, No Longer Enrolling: 10/1/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02260934

Genotype Phenotype Discordance in Polypharmacy Patients

Principal Investigator: Andrew Monte
Protocol #14-0381, No Longer Enrolling: 10/9/2020
Location: University of Colorado Hospital;

Developing biomarkers of acute alcohol exposure

Principal Investigator: Ellen Burnham
Protocol #15-1799, No Longer Enrolling: 12/28/2019
Locations: CTRC-adult; University of Colorado Hospital;

Effect of Urinary Alkalinization on Urine Uric Acid Precipitation and Crystallization in Adults with Type 1 Diabetes

Principal Investigator: Petter Bjornstad
Protocol #15-0541, No Longer Enrolling: 12/27/2019
Locations: CTRC-adult; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02502071

Vascular mechanisms for the effects of loss of ovarian hormone function on cognition in women

Principal Investigator: Kerry Hildreth
Protocol #14-0193, No Longer Enrolling: 5/20/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02122198

Effects of acetate, alcohol, and gut microbiome on brain function

Principal Investigator: Jody Tanabe
Protocol #15-0933, No Longer Enrolling: 5/22/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02542150

Comparative Effectiveness Between Long Term Fingolimod versus Glatiramer Acetate On Brain Atrophy Rates, Cognition and Patient Reported Outcomes in Patients with Multiple Sclerosis

Principal Investigator: Kavita Nair
Protocol #14-0774, No Longer Enrolling: 5/20/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02307877

HepQuant (HQ)-SHUNT Correlates of Hepatic Venous Pressure Gradient (HVPG) Testing

Principal Investigator: Amanda Wieland
Protocol #15-0520, No Longer Enrolling: 4/6/2021
Location: University of Colorado Hospital;

Outcomes of surgical and medical management of craniopharyngiomas

Protocol #17-0365, No Longer Enrolling: 10/22/2019
Location: University of Colorado Hospital;

Effects of Sofosbuvir/Ledipasvir Treatment on the Pharmacokinetcs and Renal Safety of Tenofovir

Principal Investigator: Jennifer Kiser
Protocol #15-0123, No Longer Enrolling: 5/20/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02588287

Bone and Vascular Health in Postmenopausal Women with Type 1 diabetes

Principal Investigator: Viral Shah
Protocol #15-1854, No Longer Enrolling: 9/18/2020
Location: University of Colorado Hospital;

A retrospective study of Inotuzumab Ozogamicin in children with relapsed or refractory acute lymphoblastic leukemia (ALL)

Protocol #17-0666, No Longer Enrolling: 11/7/2019
Location: Childrens Hospital Colorado;

Post Market Clinical Follow Up Evaluating the Infinity Deep Brain Stimulation Implantable Pulse Generator System

Protocol #17-0722, No Longer Enrolling: 10/1/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02989610

A Dose Frequency Optimization, Phase IIIB/IV Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects with Advanced or Metastatic Non-small Cell Lung Cancer who Received 4 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks

Principal Investigator: Sara Twombly
Protocol #16-6086, No Longer Enrolling: 7/28/2021
Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital;

More information available at ClinicalTrials.gov: NCT02713867

A Pilot Randomized Double-Blind Placebo-Controlled Phase 2 Trial of the Safety, Efficacy, and Long-Term Tolerability of GM-CSF (Leukine?) in the Treatment of Alzheimer's Disease

Protocol #17-0215, No Longer Enrolling: 10/1/2019
Location: University of Colorado Hospital;

Home or away from home: comparing clinical outcomes relevant to the care of pediatric acute myeloid leukemia during periods of neutropenia (Aim 1)

Principal Investigator: KELLY MALONEY
Protocol #17-0791, No Longer Enrolling: 12/2/2020
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT02774850

Home or Away From Home: Comparing patient and caregiver reported quality of life and other patient-centered outcomes for inpatient versus outpatient management of neutropenia in children with AML or MDS receiving standard intensive AML frontline chemotherapy

Principal Investigator: KELLY MALONEY
Protocol #17-0812, No Longer Enrolling: 6/24/2020
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT02777021

Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-936558 (nivolumab) in Participants with Severe Sepsis or Septic Shock.

Principal Investigator: Thomas Schroeppel
Protocol #17-6150, No Longer Enrolling: 5/20/2020
Location: Memorial Hospital Central;

More information available at ClinicalTrials.gov: NCT02960854

Sleep Disordered Breathing Accounts for Abnormal Glycemic Profiles in Pregnant Women: The Sleep in Pregnancy (SiP) Study

Principal Investigator: Sarah Farabi
Protocol #16-2568, No Longer Enrolling: 5/28/2021
Location: University of Colorado Hospital;

Cross-Cultural Use of Performance-Based Functional Assessment in Alzheimer's Disease

Principal Investigator: Jennifer Maitlen
Protocol #16-1954, No Longer Enrolling: 5/28/2021
Location: University of Colorado Hospital;

Retrospective study evaluating the outcomes and clinical characteristics of patients with grade 3A follicular lymphoma

Protocol #17-1041, No Longer Enrolling: 11/7/2019
Location: University of Colorado Hospital;

Retrospective study assessing radiographic parameters to predict the likelihood of relapse in patients with aggressive non-hodgkin and hodgkin lymphoma

Protocol #17-0784, No Longer Enrolling: 10/5/2019
Location: University of Colorado Hospital;

Registry of Angiovac Procedures In Detail Outcomes Database

The primary objective of this registry is to determine the procedure related mortality associated with the use of the Angiovac device. This is a FDA approved device, being used in clinical practice for the removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours.

Principal Investigator: Paul Rochon
Protocol #15-1608, No Longer Enrolling: 11/6/2020
Location: University of Colorado Hospital;

Brain metastases from endometrial cancer: a case series and literature review

Principal Investigator: Bradley Corr
Protocol #17-1222, No Longer Enrolling: 11/26/2019
Location: University of Colorado Hospital;

PHASE 2, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, DOSE-RANGING, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF CK-2127107 IN PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSIS (ALS)

Protocol #17-0734, No Longer Enrolling: 10/1/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03160898

Damage to the temporal and marginal mandibular branches of the facial nerve in Mohs Micrographic Surgery

Principal Investigator: Eileen Axibal
Protocol #17-1307, No Longer Enrolling: 11/26/2019
Location: University of Colorado Hospital;

Assessment of neuroimaging measurements in predicting post-operative outcomes following resective surgery for brain tumors

Protocol #17-1136, No Longer Enrolling: 10/18/2019
Location: University of Colorado Hospital;

Cesarean Wound Closure in Women with BMI 40 or Greater: A Randomized Controlled Trial Comparing Subcuticular Suture to Surgical Staples C: 4.0; 04/24/2017

Principal Investigator: Chanel Mansfield
Protocol #16-1748, No Longer Enrolling: 5/2/2020
Location: University of Colorado Hospital;

Early feeding following percutaneous gastrostomy tube placement

Protocol #16-1074, No Longer Enrolling: 11/14/2019
Location: University of Colorado Hospital;

The Incidence and Risk of Thrombocytopenia Following Peripheral Blood Stem Cell Donation in Adult, Related Allogeneic Donors.

Principal Investigator: Nicole Draper
Protocol #17-1336, No Longer Enrolling: 11/28/2019
Location: University of Colorado Hospital;

Multi-institutional retrospective exploratory chart review to assess the response rate to a class of drugs called poly ADP ribose polymerase inhibitors (PARPi) in patients with ovarian cancer who have previously been treated with PARPi

Protocol #17-0850, No Longer Enrolling: 11/1/2019
Location: University of Colorado Hospital;

Real-Time Sleep Stage Classification with Unobstrustive Bio-potential Recording System

Principal Investigator: Ann Halbower
Protocol #16-0328, No Longer Enrolling: 6/15/2021
Locations: Childrens Hospital Colorado; CTRC Inpatient; University of Colorado Hospital;

Lipoprotein lipase enzyme activity assay validation and clinical assessment

Principal Investigator: Robert Eckel
Protocol #15-1412, No Longer Enrolling: 1/6/2021
Location: University of Colorado Hospital;

Retrospective review of radiation oncology clinical, imaging, radiation, and outcomes data

Protocol #17-1004, No Longer Enrolling: 11/7/2019
Location: University of Colorado Hospital;

Open-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) V: 5.0; 13Mar2018

Protocol #17-1267, No Longer Enrolling: 11/2/2019
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT02562235

A Retrospective Study of Prolaris for the Prediction of Progression in Men Treated with Modern External Beam Radiation Therapy for Prostate Cancer

Protocol #16-2414, No Longer Enrolling: 10/22/2019
Location: University of Colorado Hospital;

A cluster randomized trial of a home-based intervention to increase uptake of postpartum contraceptives and its effect on short-interval pregnancy rates in a postpartum population of rural Guatemalan women

Principal Investigator: Margo Harrison
Protocol #17-1314, No Longer Enrolling: 9/10/2021
;

Virtual and Augmented Reality Study

Principal Investigator: Julie Dunn
Protocol #17-6191, No Longer Enrolling: 3/3/2021
Location: Medical Center of the Rockies;

Lifeboard Software Functionality Study

Accuracy of the software will be evaluated through case review. The cases entered into the Lifeboard software will be compared to the paper trauma flow sheet. Research staff will be comparing what is entered into the software on the tablet against the trauma flow sheet for each case.

Principal Investigator: Julie Dunn
Protocol #UCH14-1326, No Longer Enrolling: 1/6/2021
Location: Medical Center of the Rockies;

S1007: A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less. RxPONDER: A Clinical Trial Rx for Positive Node, Endocrine Responsive Breast Cancer

Protocol #UCH11-0510, No Longer Enrolling: 10/1/2019
Location: Memorial Hospital Central;

S0931: EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study

Protocol #UCH11-0716, No Longer Enrolling: 10/1/2019
Location: Memorial Hospital Central;

An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT)

Principal Investigator: Caralyn Henderson
Protocol #UCH14-0104, No Longer Enrolling: 5/19/2020
Location: Memorial Hospital Central;

Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women with Endocrine Responsive Breast Cancer

Protocol #UCH07-0207, No Longer Enrolling: 10/1/2019
Location: Memorial Hospital Central;

A PHASE III TRIAL OF 6 VERSUS 12 TREATMENTS OF ADJUVANT FOLFOX PLUS CELECOXIB OR PLACEBO FOR PATIENTS WITH RESECTED STAGE III COLON CANCER

Protocol #UCH10-0821, No Longer Enrolling: 10/1/2019
Location: Memorial Hospital Central;

A PHASE 3 OPEN-LABEL RANDOMIZED STUDY TO COMPARE THE EFFICACY AND SAFETY OF RITUXIMAB PLUS LENALIDOMIDE (CC-5013) VERSUS RITUXIMAB PLUS CHEMOTHERAPY FOLLOWED BY RITUXIMAB IN SUBJECTS WITH PREVIOUSLY UNTREATED FOLLICULAR LYMPHOMA

Protocol #UCH11-1023, No Longer Enrolling: 10/1/2019
Location: Memorial Hospital Central;

E1505: A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (!Y 4 cm) - IIIA Non-Small Cell Lung Cancer (NSCLC)

Protocol #UCH09-0308, No Longer Enrolling: 10/1/2019
Location: Memorial Hospital Central;

E1609 A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High-Dose Interferon a-2b for Resected High-Risk Melanoma

Protocol #UCH11-0715, No Longer Enrolling: 10/1/2019
Location: Memorial Hospital Central;

Retrospective review of clinical and dosimetric data for breast cancer patients receiving radiotherapy

Protocol #17-0380, No Longer Enrolling: 11/1/2019
Locations: Memorial Hospital Central; Memorial Hospital North;

E5202: A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers

Protocol #UCH09-1018, No Longer Enrolling: 10/1/2019
Location: Memorial Hospital Central;

Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment: The TAILORx Trial

Protocol #UCH06-0629, No Longer Enrolling: 10/1/2019
Location: Memorial Hospital Central;

S0221: Phase III Trial of Continuous Schedule AC + G Vs. Q 2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High- Risk Node Negative Breast Cancer

Protocol #UCH07-0623, No Longer Enrolling: 10/1/2019
Location: Memorial Hospital Central;

S0307: Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer

Protocol #UCH06-0730, No Longer Enrolling: 10/1/2019
Location: Memorial Hospital Central;

A Phase 2, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of neurobehavioral disinhibition including aggression, agitation, and irritability in patients with traumatic brain injury (TBI).

Structure: This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study. Duration: Patients will be enrolled in the study for up to 16 weeks, with up to a 4-week screening period and a 12-week treatment period. Study Treatment: The investigational product is AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]), which is titrated over a 2-week period to d6-DM 42.63 mg/Q 4.9 mg (AVP-786-42.63/4.9) twice daily (BID). Control: Placebo capsules appearing identical to study medication will be used as control. Randomization: Eligible patients will be randomized into the study to receive AVP-786 or placebo. Dose Regimen:

Principal Investigator: Julie Dunn
Protocol #17-6198, No Longer Enrolling: 3/24/2021
Location: Medical Center of the Rockies;

More information available at ClinicalTrials.gov: NCT03095066

RTOG 0129: A PHASE III TRIAL OF CONCURRENT RADIATION AND CHEMOTHERAPY (FOLLOWED BY SURGERY FOR RESIDUAL PRIMARY/N2-3 NODAL DISEASE) FOR ADVANCED HEAD AND NECK CARCINOMAS

Protocol #UCH02-1026, No Longer Enrolling: 10/1/2019
Location: Memorial Hospital Central;

A Phase 2, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of neurobehavioral disinhibition including aggression, agitation, and irritability in patients with traumatic brain injury (TBI).

Principal Investigator: Paul Reckard
Protocol #17-6199, No Longer Enrolling: 5/19/2020
Location: Memorial Hospital Central;

More information available at ClinicalTrials.gov: NCT03095006

GORE? HELEX? Septal Occluder / GORE? Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke or Imaging- Confirmed TIA in Patients with Patent Foramen Ovale (PFO)

Principal Investigator: John Carroll
Protocol #13-3034, No Longer Enrolling: 4/2/2021
Location: University of Colorado Hospital;

The influence of gonadal hormone suppression on adipocyte lineage and the microbiome

Six month intervention of ovarian hormone supressionThis research study plans to learn more about the role of female sex hormones on fat and the gut microbiome (or the organisms that are in your digestive tract).

Principal Investigator: Kathleen Gavin
Protocol #17-1869, No Longer Enrolling: 8/19/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03396978

VEIN OF MARSHALL ETHANOL INFUSION FOR PERSISTENT ATRIAL FIBRILLATION

Protocol #16-1551, No Longer Enrolling: 10/1/2019
Location: University of Colorado Hospital;

MONALEESA-3: A randomized double-blind, placebocontrolledstudy of ribociclib in combination withfulvestrant for the treatment of postmenopausal womenwith hormone receptor positive, HER2-negative, advancedbreast cancer who have received no or only one line ofprior endocrine treatment

To compare PFS between ribociclib in combination with fulvestrant to placebo in combination with fulvestrant among postmenopausal women with HR+, HER2-negative advanced breast cancer who received no or only one prior endocrine treatment for advanced disease

Principal Investigator: Steven Schuster
Protocol #15-6019, No Longer Enrolling: 1/29/2020
Locations: Greeley Hospital; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital;

More information available at ClinicalTrials.gov: NCT02422615

A multicenter, randomized, open-label Phase 2 studyevaluating the safety and efficacy of three differentregimens of oral panobinostat in combination withsubcutaneous bortezomib and oral dexamethasone inpatients with relapsed or relapsed/refractory multiplemyeloma who have been previously exposed to immunomodulatory agents

Protocol #16-6057, No Longer Enrolling: 10/1/2019
Locations: Greeley Hospital; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital;

A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries

Principal Investigator: Scott Kaczkowski
Protocol #UCH12-1142, No Longer Enrolling: 5/20/2020
;

Prospective, Randomized, SingLe-Blind, U.S. MuLti-Center Study to EvalUate TreatMent of obstructive SupErficial Femoral Artery or Popliteal LesioNs With A Novel Paclitaxel-CoatEd Percutaneous Angioplasty Balloon

Principal Investigator: Scott Kaczkowski
Protocol #UCH13-1272, No Longer Enrolling: 5/20/2020
;

Influence of PTSD Symptoms on Chronic Pain Development After Sexual Assault

Principal Investigator: Megan Lechner
Protocol #15-6021, No Longer Enrolling: 1/6/2021
Location: Memorial Hospital Central;

A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women with Endocrine Responsive Breast Cancer (SOFT)

Principal Investigator: Steven Schuster
Protocol #UCH04-680, No Longer Enrolling: 5/20/2020
Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital;

More information available at ClinicalTrials.gov: NCT00975676

S0820: A DOUBLE BLIND PLACEBO-CONTROLLED TRIAL OF EFLORNITHINE AND SULINDAC TO PREVENT RECURRENCE OF HIGH RISK ADENOMAS AND SECOND PRIMARY COLORECTAL CANCERS IN PATIENTS WITH STAGE 0-III COLON OR RECTAL CANCER, PHASE III-PREVENTING ADENOMAS OF THE COLON WITH EFLORNITHINE AND SULINDAC (PACES) V: 7/2/18

Protocol #UCH13-1260, No Longer Enrolling: 11/7/2019
Locations: Greeley Hospital; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital;

ALTE16C1: Effects of Modern Chemotherapy Regimens on Spermatogenesis and Steroidogenesis in Adolescent and Young Adult (AYA) Survivors of Osteosarcoma

Principal Investigator: Tim Garrington
Protocol #17-2472, No Longer Enrolling: 12/2/2020
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT03206450

Compassionate use of Lorcaserin in Dravet Syndrome

Compassionate use of Lorcaserin in Dravet Syndrome

Protocol #14-2440, No Longer Enrolling: 10/1/2019
Location: Childrens Hospital Colorado;

Can the cervical spine be clinically cleared in awake and alert blunt trauma patients with "distracting injuries"?

Principal Investigator: Thomas Schroeppel
Protocol #17-6220, No Longer Enrolling: 5/20/2020
Location: Memorial Hospital Central;

Trauma ICU Prevelance Project (TRIPP study) - an American Association for the Surgery of Trauma Multi-institutional Study

Principal Investigator: Thomas Schroeppel
Protocol #18-6038, No Longer Enrolling: 5/20/2020
Location: Memorial Hospital Central;

Unrelated Donor Transplant versus Immune Therapy in Pediatric Severe Aplastic Anemia (TransIT)

Principal Investigator: Taizo Nakano
Protocol #18-0524, No Longer Enrolling: 7/31/2021
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT02845596

Evaluation of Physiologic Characteristics and Clinical Outcomes of Patients with Cardiac Arrythmias Referred for Treatment in the Cardiac Electrophysiology Section

Protocol #16-0996, No Longer Enrolling: 10/1/2019
Location: University of Colorado Hospital;

The Longitudinal Surveillance Study of the 4-SITE Lead/Header System

Principal Investigator: Mercedes Zirbes
Protocol #13-2415, No Longer Enrolling: 5/2/2020
;

Antiviral Cellular Therapy for Enhancing T-cell Reconstitution Before or After Hematopoietic Stem Cell Transplantation (ACES) PBMTC SUP1701

Principal Investigator: Michael Verneris
Protocol #18-0834, No Longer Enrolling: 3/2/2021
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT03475212

Compassionate use of Kalydeco-L-M (single patient IND #129,402)

Protocol #15-2421, No Longer Enrolling: 10/1/2019
Location: Childrens Hospital Colorado;

PBTC-050: A Phase I and Surgical Study of Ribociclib and Everolimus (RAD001) in Children with Recurrent or Refractory Malignant Brain Tumors

Principal Investigator: Carmen Rivera
Protocol #18-0947, No Longer Enrolling: 4/18/2020
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT03387020

Assessment of the Current Status and Needs for Residency Training on Physics Plan Reviews

Principal Investigator: LEAH SCHUBERT
Protocol #18-1073, No Longer Enrolling: 11/28/2019
Location: University of Colorado Hospital;

PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF RELTECIMOD AS COMPARED TO PLACEBO IN ADDITION TO STANDARD OF CARE IN PATIENTS WITH SEPSIS-ASSOCIATED ACUTE KIDNEY INJURY (SA-AKI). 10DEC2017

Principal Investigator: Lisa Ferrigno
Protocol #18-1095, No Longer Enrolling: 4/7/2020
Locations: Memorial Hospital Central; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03403751

Major Differences in Treatment and Practice Settings for Patients with Acute Lymphoblastic Leukemia

Protocol #18-1031, No Longer Enrolling: 10/31/2019
Location: University of Colorado Hospital;

A Survey Study Examining Cannabis Use in for Cancer Care in Gynecologic Oncology Patients

Protocol #18-1096, No Longer Enrolling: 10/22/2019
Location: University of Colorado Hospital;

Imaging Early Ovarian Cancer Study: Multi-Institutional study by Society of Abdominal radiology; Uterine Ovarian Cancer Panel

Protocol #18-1143, No Longer Enrolling: 10/22/2019
Location: University of Colorado Hospital;

A Multicenter Retrospective Review of Pediatric Differentiated Thyroid Cancer

Protocol #18-0795, No Longer Enrolling: 11/1/2019
Locations: Childrens Hospital Colorado; University of Colorado Hospital;

Post-operative outcomes for nervus intermedius function following acoustic neuroma resection

Protocol #18-1176, No Longer Enrolling: 10/22/2019
Location: University of Colorado Hospital;

Targeting MCJ/DNAJC15 and the mitochondrial electron transport chain in acute myeloid leukemia

Principal Investigator: James DeGregori
Protocol #18-1227, No Longer Enrolling: 11/28/2019
Location: University of Colorado Hospital;

Endocrinopathies in immunotherapy; A retrospective study to evaluate the incidence, risk factors for and clinical implications of immunotherapy induced hypoglycemia.

Protocol #18-1251, No Longer Enrolling: 11/7/2019
Location: University of Colorado Hospital;

Screening and Surveillance in PCC/PGL Susceptibility Gene Mutation Carriers

Principal Investigator: Lauren Fishbein
Protocol #18-1240, No Longer Enrolling: 11/28/2019
Locations: Childrens Hospital Colorado; University of Colorado Hospital;

Second opinion review of outside breast imaging: an analysis of the frequency that additional testing is recommended and radiology/pathology outcomes

Principal Investigator: Gretchen Ahrendt
Protocol #18-1123, No Longer Enrolling: 11/28/2019
Location: University of Colorado Hospital;

Optimizing delivery of tumor molecular profile information

Principal Investigator: Matthew Rioth
Protocol #18-1084, No Longer Enrolling: 11/28/2019
Location: University of Colorado Hospital;

A comparison of the immunogenicity and descriptive safety of a live attenuated herpes zoster vaccine and the GSK herpes zoster recombinant HZ/su candidate vaccine in 50-59 year old and 70-85 year old vaccine recipients.

Principal Investigator: Myron Levin
Protocol #13-3192, No Longer Enrolling: 9/10/2021
Location: Adult Infectious Disease Clinical Trials Center;

More information available at ClinicalTrials.gov: NCT02114333

Post-operative reconstruction techniques after translabyrinthine craniotomy: comparison of autologous cranioplasty versus cement reconstruction on functional outcomes and quality of life

Protocol #18-1177, No Longer Enrolling: 10/22/2019
Location: University of Colorado Hospital;

Safety and Efficacy of Immune Checkpoint Inhibitors in Renal and Bladder Cancer Patients with Pre-existing Autoimmune Disorders (Retrospective Study)

Protocol #18-2184, No Longer Enrolling: 10/31/2019
Locations: Lone Tree Medical Center; University of Colorado Hospital;

A Humanitarian Device Exemption Treatment Protocol of TheraSphere for Treatment of Unresectable Primary or Secondary Liver Neoplasia

Protocol #07-0084, No Longer Enrolling: 10/22/2019
Location: University of Colorado Hospital;

Risk factors for molecular subtypes of NHL - a prospective evaluation

Protocol #17-0640, No Longer Enrolling: 10/18/2019
Location: University of Colorado Hospital;

Glioma Longitudinal Analysis Consortium

Protocol #18-2263, No Longer Enrolling: 10/22/2019
Location: University of Colorado Hospital;

Efficacy of clofarabine with cytarabine and granulocyte colony-stimulating factor for relapsed and refractory acute myeloid leukemia: a single-center experience

Principal Investigator: Joanna Huang
Protocol #18-2186, No Longer Enrolling: 11/28/2019
Location: University of Colorado Hospital;

Assessment of potential predicative and prognostic factors in patients with solid tumors receiving single agent check point inhibitor

Principal Investigator: Tiba Al Sagheer
Protocol #18-2272, No Longer Enrolling: 11/28/2019
Location: University of Colorado Hospital;

EsVan Infection Risk Prediction Model in Non-Neutropenic Pediatric Oncology Patients

Principal Investigator: Jenna Sopfe
Protocol #18-2257, No Longer Enrolling: 11/28/2019
Location: Childrens Hospital Colorado;

Harnessing the Principles of Visual Perceptual Learning for Training Observers to Interpret Mammography

Principal Investigator: Eric Rosen
Protocol #18-2077, No Longer Enrolling: 11/28/2019
Location: University of Colorado Hospital;

Addressing Urban Rural Disparities in Cancer: The Case for Registry Expansion

Principal Investigator: Cathy Bradley
Protocol #18-2442, No Longer Enrolling: 11/28/2019
Location: University of Colorado Cancer Center;

Laboratory-Based Investigations of Primary Leukemia and Myelodysplastic Syndrome Samples from the Hematologic Tissue Bank

Principal Investigator: Derek Schatz
Protocol #18-2461, No Longer Enrolling: 11/28/2019
Location: University of Colorado Hospital;

Dissecting the Role of Inflammation in Smoking and Aging Associated Lung Cancers

Principal Investigator: James DeGregori
Protocol #18-2584, No Longer Enrolling: 11/28/2019
Location: Rocky Mountain Regional VA Medical Center;

Enhancing Efficacy of Checkpoint Inhibitors through VEGF Blockade in Sarcomas

Protocol #18-2499, No Longer Enrolling: 10/28/2019
Location: University of Colorado Hospital;

Nervus intermedius outcomes after vestibular schwannoma surgery

Principal Investigator: Samy Youssef
Protocol #18-2590, No Longer Enrolling: 11/28/2019
Location: University of Colorado Hospital;

Understanding Barriers to Enrollment in Clinical Trials at the University of Colorado Cancer Center

Principal Investigator: Christan Bartsch
Protocol #18-2684, No Longer Enrolling: 8/4/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT00000000

Evaluation of the treatment of coagulase negative staphylococci identified in blood cultures of outpatient stem cell transplant patients

Principal Investigator: Laura Cannon
Protocol #18-2701, No Longer Enrolling: 11/28/2019
Location: University of Colorado Hospital;

An Exploratory Investigation of the Impact of the Assistive Technology Partners Product Testing Laboratory

Principal Investigator: Greg McGrew
Protocol #11-0674, No Longer Enrolling: 10/9/2021
Locations: Memorial Hospital Central; Memorial Hospital North;

Use of a Pharmacy Managed Empiric Continuous Infusion Vancomycin Protocol in Pediatrics

Principal Investigator: Courtney Holmes
Protocol #18-6128, No Longer Enrolling: 5/20/2020
Location: Memorial Hospital Central;

Community Cancer Needs Evaluation Project

Protocol #18-2699, No Longer Enrolling: 10/22/2019
Location: University of Colorado Hospital;

Analyzing variations in pre-operative imaging for patients with newly diagnosed breast cancer using the SEER-Medicare database

Principal Investigator: Sarah Tevis
Protocol #18-2828, No Longer Enrolling: 11/28/2019
Location: University of Colorado Hospital;

NCCN Best Practices Psychologist Staffing Metrics Survey

Protocol #18-2840, No Longer Enrolling: 11/19/2019
Location: University of Colorado Hospital;

Caretaker Wireless Vital Sign Monitor Applied in the Field and Transitioned into the Emergency Department: A Quality Initiative Project to Determine the Efficacy of the Caretaker Device Compared to Standard Vital Sign Recordings

To test wireless vital sign monitor in the field and determine feasibility.

Principal Investigator: Julie Dunn
Protocol #18-6102, No Longer Enrolling: 3/5/2021
Location: Medical Center of the Rockies;

Blood Transfusion During Hepatectomy

Protocol #18-2887, No Longer Enrolling: 10/30/2019
Location: University of Colorado Hospital;

Clinical data paired with omics profiling of leukemic stem cells in patients with AML to predict the likelihood of treatment failure with Venetoclax plus azacytidine and direct patients to optimal therapy

Protocol #19-0522, No Longer Enrolling: 10/23/2019
Location: University of Colorado Hospital;

The Perelman Study of IntraUterine Growth Restriction

Principal Investigator: Camille Driver
Protocol #14-1360, No Longer Enrolling: 10/9/2021
Locations: Childrens Hospital Colorado; University of Colorado Hospital;

Patient distress at the time of breast cancer diagnosis

Protocol #19-0693, No Longer Enrolling: 11/1/2019
Location: University of Colorado Hospital;

Integration of Specialty Palliative Care in a Phase I Ovarian Cancer Population

Protocol #19-0653, No Longer Enrolling: 10/28/2019
Location: University of Colorado Hospital;

Outcomes Research for Patients Undergoing Treatment for Cutaneous Squamous Cell Carcinoma at the University of Colorado

Protocol #19-0950, No Longer Enrolling: 11/16/2019
Location: University of Colorado Hospital;

Midostaurin (Rydapt), liquid formulation, emergency sIND

Protocol #19-6064, No Longer Enrolling: 10/1/2019
Locations: Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital;

Retrospective Review of Cyclophosphamide in the Treatment of Prostate Cancer

Protocol #19-0973, No Longer Enrolling: 11/1/2019
Location: University of Colorado Hospital;

Reliability of Fluorescein-assisted Stereotactic Brain Biopsies in Predicting Conclusive Tissue Diagnosis

Principal Investigator: Edin Nevzati
Protocol #19-1028, No Longer Enrolling: 12/28/2019
Location: University of Colorado Hospital;

Retrospective analysis of radiotherapy plus concomitant temozolomide in meningioma treatment

Protocol #19-1089, No Longer Enrolling: 11/7/2019
Location: University of Colorado Hospital;

Retrospective study of the prevalence and outcomesvof children with cancer at the Jose Renan Esquivel Hospital (HJRE) and Hospital Materno Infantil Jose Domingo Obadia (HMIJDO) of Panama City and Chiriqui, Panama

Protocol #19-1136, No Longer Enrolling: 11/7/2019
;

Non-operative management of suspected Calvarial Langerhans Cell Histiocytosis V: 20March2017

Protocol #13-2571, No Longer Enrolling: 10/1/2019
Location: Childrens Hospital Colorado;

Prevalence of malignancy in incidentally detected homogeneous renal masses measuring 21-39 Hounsfield units on portal venous-phase CT: A multi-institutional retrospective cohort study

Protocol #19-1306, No Longer Enrolling: 10/22/2019
Location: University of Colorado Hospital;

Outcomes of Oligometastatic Renal Cell Carcinoma to Pancreas

Protocol #19-1465, No Longer Enrolling: 10/31/2019
Location: University of Colorado Hospital;

Single Patient IND for sEphB4-HSA, IND#144870

Protocol #19-1388, No Longer Enrolling: 10/1/2019
Location: University of Colorado Hospital;

Intra articular injections with platelet rich plasma in patients with Juvenile Osteochondritis Dissecans of the knee: Does it Help? A clinical and MR study

Protocol #13-2797, No Longer Enrolling: 10/4/2019
Location: Childrens Hospital Colorado;

Single Patient IND for idebenone, IND# 145007, NSL

Protocol #19-1495, No Longer Enrolling: 10/1/2019
Location: University of Colorado Hospital;

Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults with ADPKD

Principal Investigator: Kristen Nowak
Protocol #15-0902, No Longer Enrolling: 7/8/2021
Locations: Childrens Hospital Colorado; Colorado Research Center;

Prospective, observational, multi-center cohort study of venous thromboembolism outcomes in thrombocytopenic cancer patients (TROVE Study)

Principal Investigator: Derek Schatz
Protocol #18-1461, No Longer Enrolling: 1/6/2021
Location: University of Colorado Hospital;

A retrospective review of locally advanced pancreatic adenocarcinoma outcomes within the University of Colorado Health system by neoadjuvant chemotherapy dosing and tumor marker levels

Protocol #17-1414, No Longer Enrolling: 11/7/2019
Location: Colorado Research Center;

Molecular characterization and treatment exploration in hormone therapy-resistant breast cancer

Protocol #17-1411, No Longer Enrolling: 10/22/2019
Location: University of Colorado Hospital;

Retrospective analysis of Invasive Mucormycosis in patients with hematologic malignancies and hematopoietic stem cell transplant recipients in the era of new anti-fungals

Protocol #17-1591, No Longer Enrolling: 11/7/2019
Location: University of Colorado Hospital;

Extracolonic Cancer Risks in Monoallelic and Biallelic MutYH Carriers

Principal Investigator: Valerie Slegesky
Protocol #17-1378, No Longer Enrolling: 11/28/2019
Location: University of Colorado Hospital;

Avascular Necrosis Secondary to the Treatment of Leukemia in the Pediatric Population

Principal Investigator: Jesse Roberts
Protocol #17-1401, No Longer Enrolling: 11/28/2019
Location: Childrens Hospital Colorado;

External Reproducibility Study of SK005 PD-L1 IHC 28-8 pharmDx on Gastric Gastroesophageal Junction Specimens

Principal Investigator: Chris Rivard
Protocol #17-1798, No Longer Enrolling: 11/28/2019
Location: University of Colorado Hospital;

Bone Morphogenetic Proteins in Bone Metastases

Principal Investigator: Philip Owens
Protocol #17-1733, No Longer Enrolling: 11/28/2019
Location: University of Colorado Hospital;

A retrospective review of dose adjustments for 5-fluorouracil based regimens at the University of Colorado Cancer Center

Protocol #17-1942, No Longer Enrolling: 10/19/2019
Location: University of Colorado Hospital;

Ovarian Cancer: An interdisciplinary approach for the identification of novel therapeutic targets.

Principal Investigator: Kian Behbakht
Protocol #17-1794, No Longer Enrolling: 11/28/2019
Location: University of Colorado Hospital;

Ovarian Cancer: An interdisciplinary approach for the identification of novel diagnostic biomarkers and therapeutic targets

Principal Investigator: Benjamin Bitler
Protocol #18-0119, No Longer Enrolling: 11/28/2019
Location: University of Colorado Hospital;

Redefining natural history of smoldering multiple myeloma and developing a new risk stratification system

Protocol #17-1753, No Longer Enrolling: 10/18/2019
Location: University of Colorado Hospital;

Retrospective study assessing the utility of cardiooncology follow up post completion of chemotherapy on identifying cardiotoxicity risk and short-term incidence and pattern of cardiotoxicity

Protocol #17-1763, No Longer Enrolling: 10/18/2019
Location: University of Colorado Hospital;

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of Evaluating the Safety and Efficacy of Intravenous Delivery of Allogeneic Cardiosphere-Derived Cells in Subjects with Duchenne Muscular Dystrophy (HOPE-2) V: 4.0 / 17Jan2019

Protocol #18-0079, No Longer Enrolling: 10/1/2019
Location: Childrens Hospital Colorado;

Preoperative ligation of ethmoid arteries in resection of anterior fossa meningiomas

Protocol #17-2115, No Longer Enrolling: 10/22/2019
Location: University of Colorado Hospital;

Post-operative imaging after pituitary tumor resection

Protocol #17-2116, No Longer Enrolling: 10/22/2019
Location: University of Colorado Hospital;

Development and Dissemination of KiNet: An Imaging Informatics Tool for Ki67 Counting in Neuroendocrine Tumor

Principal Investigator: Fuyong Xing
Protocol #17-2167, No Longer Enrolling: 11/28/2019
Location: University of Colorado Hospital;

Disorders of Sex Development and Malignant Germ Cell Tumors

Principal Investigator: Amanda Saltzman
Protocol #17-2142, No Longer Enrolling: 11/28/2019
Location: Childrens Hospital Colorado;

Retrospective Analysis of Patients with Small-Cell Lung Cancer (SCLC) Managed with Radiosurgery for Brain Metastases

Protocol #18-0080, No Longer Enrolling: 11/7/2019
Location: University of Colorado Hospital;

PET Parameters in Differentiating Low-Grade versus Grade 3A Follicular Lymphoma

Protocol #18-0023, No Longer Enrolling: 11/14/2019
Location: University of Colorado Hospital;

Investigating alterations in molecular pathways in human epithelial ovarian cancer tumors

Principal Investigator: Benjamin Bitler
Protocol #17-7788, No Longer Enrolling: 11/28/2019
Location: University of Colorado Hospital;

Retrospective Analysis of Patients treated with Radiosurgery for Brain Metastases from ALK Rearranged and EGFR Mutated NSCLC

Protocol #18-0081, No Longer Enrolling: 11/7/2019
Location: University of Colorado Hospital;

Harnessing principles of visual perceptual learning to improve breast cancer detection by developing evidence based training techniques

Principal Investigator: Eric Rosen
Protocol #18-0094, No Longer Enrolling: 11/28/2019
Location: University of Colorado Hospital;

Machine Learning Technology as a Diagnostic Tool in Medulloblastoma and Ependymoma

Principal Investigator: Arthur Liu
Protocol #18-0201, No Longer Enrolling: 11/28/2019
Locations: Childrens Hospital Colorado; University of Colorado Hospital;

Retrospective study to establish clinical or imaging characteristics of bone and soft tissue tumor that may affect outcomes following percutaneous ablation

Protocol #18-0357, No Longer Enrolling: 11/7/2019
Location: University of Colorado Hospital;

Intraoperative sodium fluorescein for tissue biopsy and resection of spinal cord lesions

Principal Investigator: Peter Witt
Protocol #18-0335, No Longer Enrolling: 11/28/2019
Location: University of Colorado Hospital;

Treatment of Advanced Hepatocellular Carcinoma With DEB-TACE

Protocol #18-0409, No Longer Enrolling: 10/22/2019
Location: University of Colorado Hospital;

The impact of utilizing radiation therapy planning CT on FDG PET/CT interpretation

Principal Investigator: Hilary Van Noort
Protocol #18-0515, No Longer Enrolling: 11/28/2019
Location: University of Colorado Hospital;

The Effect of Cervical Cancer Screening on the Incidence Rate of Invasive Cervical Carcinoma in HIV-positive Women in Lusaka, Zambia

Principal Investigator: Yuli Chen
Protocol #18-0528, No Longer Enrolling: 11/28/2019
Location: University of Colorado Hospital;

Racial disparities in cancer treatment, patient-experiences with medical care, patient-reported outcomes, and mortality among cancer patient

Protocol #18-0597, No Longer Enrolling: 10/18/2019
Locations: University of Colorado Hospital; University of Southern California;

Safety of Dalteparin Antithrombotic Therapy in Patients with Cancer-Associated Thromboembolism

Protocol #18-0636, No Longer Enrolling: 10/31/2019
Location: University of Colorado Hospital;

Koebnerizing squamous cell carcinoma treated with intralesional 5-fluouracil

Principal Investigator: Mariah Brown
Protocol #18-0596, No Longer Enrolling: 11/28/2019
Location: University of Colorado Hospital;

Risk Factors for Acquired Immune Deficiency Syndrome-Associated Kaposi sarcoma AIDS-KS) Mortality among Zimbabwean Adults (A sub-study of Strategies to Improve Kaposi Sarcoma (KS) Outcomes in Zimbabwe (SIKO))

Principal Investigator: Katherine Sabourin
Protocol #18-0749, No Longer Enrolling: 11/28/2019
;

Predictors of childhood obesity in cancer survivors

Principal Investigator: Bonnie Gance-Cleveland
Protocol #18-0263, No Longer Enrolling: 11/28/2019
Location: University of Colorado Hospital;

Comparison of Tomosynthesis and Digital Mammography for Breast Cancer Screening

Principal Investigator: Hilary Van Noort
Protocol #18-0717, No Longer Enrolling: 11/28/2019
Location: University of Colorado Hospital;

Effect of Rotational Angiography on Radiation Exposure During Percutaneous Liver Directed Therapy in Interventional Radiology

Principal Investigator: Hilary Van Noort
Protocol #18-0726, No Longer Enrolling: 11/28/2019
Location: University of Colorado Hospital;

A Retrospective Record Review of Mobilization Strategies with and without Plerixafor for Autologous Stem Cell Transplant in Patients with Multiple Myeloma

Protocol #18-0748, No Longer Enrolling: 10/18/2019
Location: University of Colorado Hospital;

Lynch Syndrome: Further Defining the Pediatric Spectrum

Principal Investigator: Alexandra Suttman
Protocol #18-0598, No Longer Enrolling: 11/28/2019
Location: Childrens Hospital Colorado;

Evaluation of recurrent breast cancer in women diagnosed with DCIS treated only with mastectomy

Protocol #18-0776, No Longer Enrolling: 10/25/2019
Location: University of Colorado Hospital;

Targeted therapy for pediatric low-grade glioma and plexiform neurofibromas with trametinib

Principal Investigator: Elizabeth Chick
Protocol #18-1383, No Longer Enrolling: 11/28/2019
Location: Childrens Hospital Colorado;

Computational Phenotyping of Cancer Antecedents and Outcomes

Principal Investigator: Matthew Rioth
Protocol #18-0848, No Longer Enrolling: 11/28/2019
Location: University of Colorado Hospital;

Practice patterns and incidence of adenovirus infections in hematopoietic cell transplant in the United States: AdVance US

Principal Investigator: Roger Giller
Protocol #18-1420, No Longer Enrolling: 11/28/2019
Location: Childrens Hospital Colorado;

Retrospective study to assess the effect of androgen deprivation therapy on imaging findings in the prostate on multiparametric prostate MRI

Protocol #18-1278, No Longer Enrolling: 10/22/2019
Location: University of Colorado Hospital;

Retrospective study to assess the variation of number of cases ordered and performed through out the year of testicular ultrasounds

Protocol #18-1277, No Longer Enrolling: 11/7/2019
Location: University of Colorado Hospital;

Liposomal Doxorubicin MUE: An evaluation of ejection fraction assessment in breast and ovarian cancer patients receiving liposomal doxorubicin at the University of Colorado Hospital and Cancer Center

Principal Investigator: Sherry Osceola
Protocol #18-1453, No Longer Enrolling: 11/28/2019
Location: University of Colorado Hospital;

Breast Cancer Brain Metastases Localization to Regions with Increased Estrogen Production

Protocol #18-1720, No Longer Enrolling: 10/22/2019
Location: University of Colorado Hospital;

Estimating Community-Level HPV Vaccine Coverage for Better Targeted Vaccination Uptake Interventions

Protocol #18-1732, No Longer Enrolling: 10/22/2019
Location: University of Colorado Hospital;

Surgically Treated Biphenotypic (Hepatobilliary) Primary Liver Carcinomas A Multicenter Review

Principal Investigator: Kendra Conzen
Protocol #18-1708, No Longer Enrolling: 11/28/2019
Location: University of Colorado Hospital;

Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or large B-cell lymphoma patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release

Principal Investigator: AMY KEATING
Protocol #18-1943, No Longer Enrolling: 11/28/2019
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT03601442

Molecular Genomic Profiling of Glassy Cell Cervical Carcinoma

Principal Investigator: MIRIAM POST
Protocol #18-1898, No Longer Enrolling: 11/28/2019
Location: University of Colorado Hospital;

Patient derived cell lines and ex vivo slice cultures for evaluation of autophagy inhibition in central nervous system tumors

Principal Investigator: Jean Mulcahy-Levy
Protocol #18-1815, No Longer Enrolling: 11/28/2019
Location: Childrens Hospital Colorado;

Evaluation of breast asymmetries with 3D mammography; can biopsy be avoided?

Principal Investigator: Eric Rosen
Protocol #18-1634, No Longer Enrolling: 11/28/2019
Location: University of Colorado Hospital;

Identifying cancer biomarkers using natural-language processing methods

Principal Investigator: Myles Cockburn
Protocol #18-1987, No Longer Enrolling: 11/28/2019
Location: University of Colorado Hospital;

Precision treatment of acute myeloid leukemia

Principal Investigator: Clay Smith
Protocol #18-1861, No Longer Enrolling: 11/28/2019
Location: University of Colorado Hospital;

Single Patient IND for ATA129, IND# [IND#], Patient JB

Protocol #19-2297, No Longer Enrolling: 11/1/2019
Location: Childrens Hospital Colorado;

A Phase 1b/2, Open-Label, Multicenter Dose-Escalation and Dose-Expansion Study of the Combination of RMC-4630 and Cobimetinib in Adult Participants with Relapsed/Refractory Solid Tumors and a Phase 1b Study of RMC-4630 with Osimertinib in Participants with Epidermal Growth Factor Receptor Mutation Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Principal Investigator: Jose Pacheco
Protocol #19-1132, No Longer Enrolling: 7/29/2021
Locations: Lone Tree Medical Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03989115

Current status of Neurosurgical Oncology in Tanzania: Opportunities for international Collaboration

Protocol #19-1766, No Longer Enrolling: 10/22/2019
Location: University of Colorado Hospital;

Immunohistochemical characterization of archival surgical lung pathology specimens

Principal Investigator: Carlyne Cool
Protocol #19-1742, No Longer Enrolling: 12/24/2019
Location: University of Colorado Hospital;

Vestibular nerve preservation in vestibular schwannoma surgery for facial and cochlear nerve function preservation

Protocol #19-1970, No Longer Enrolling: 10/22/2019
Location: University of Colorado Hospital;

Single Patient IND for Tisagenlecleucel (CTL019), IND#18474

Protocol #18-1940, No Longer Enrolling: 11/1/2019
Location: Childrens Hospital Colorado;

The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension

Principal Investigator: Rachael Burnett
Protocol #19-0159, No Longer Enrolling: 8/15/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03614260

A Phase 2a, Randomized, Open-Label, Active Control, Multi-Center Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de novo Kidney Transplant Recipients

This is a Phase 2a, randomized, open-label, active control, multi-center study to assess the efficacy and safety of bleselumab in preventing the rFSGS in de novo kidney transplant subjects.Primary Objective: - To assess the efficacy of the bleselumab regimen (basiliximab induction, tacrolimus, steroids and bleselumab) compared with the SOC regimen (basiliximab induction, tacrolimus, steroids and MMF) in the prevention of the recurrence of focal segmental glomerulosclerosis (rFSGS) defined as nephrotic range proteinuria with proteincreatinine ratio (> or equal to 3.0 g/g) through 3 months post-transplant. Death, graft loss or lost to follow-up will be imputed as rFSGS. Secondary Objectives: - To assess the incidence of nephrotic range proteinuria with protein-creatinine ratio (> or equal to 3.0 g/g) through 6 and 12 months post-transplant. Death, graft loss or lost to follow-up will be imputed as rFSGS. - To assess the incidence of biopsy-proven acute rejection (BPAR, Banff Grade ≥ 1; local read) through 3, 6 and 12 months post-transplant. - To assess the incidence of efficacy failure defined as BPAR (Banff Grade ≥ 1; local read), death, graft loss or lost to follow-up through 12 months post-transplant. - To assess the incidence of biopsy-proven (blinded, central read) rFSGS through 3, 6 and 12 months post-transplant. - To assess the safety of the bleselumab regimen compared with the SOC regimen.

Principal Investigator: Alexander Wiseman
Protocol #17-1010, No Longer Enrolling: 10/10/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02921789

Effect of breaking up prolonged sitting on metabolic flexibility

Our objective is to test the effect of breaking-up prolonged sitting with bouts of physical activity on metabolic flexibility, a recognized core component of metabolic health. Metabolic flexibility is defined as the body's ability to adapt fuel oxidation to changing fuel availability and energy demands.

Principal Investigator: Audrey Bergouignan
Protocol #14-0429, No Longer Enrolling: 5/20/2021
Locations: CTRC-adult; University of Colorado Hospital;

Immune Profiling of Squamous Cell Carcinomas

Principal Investigator: Jing Wang
Protocol #16-2436, No Longer Enrolling: 11/23/2019
Location: University of Colorado Hospital;

Using chronic epilepsy monitoring to study the role of parietal and occipital cortex in movement initiation and perception

Principal Investigator: John Thompson
Protocol #17-0321, No Longer Enrolling: 5/2/2020
Location: University of Colorado Hospital;

A Phase I study of Anetumab Ravtansine in Combination with either Anti-PD-1 Antibody, or Anti-CTLA4 and Anti-PD-1 Antibodies or Anti-PD-1 Antibody and Gemcitabine in Mesothelin-Positive Advanced Pancreatic Adenocarcinoma

Principal Investigator: Matthew Lee
Protocol #19-0821, No Longer Enrolling: 3/13/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03816358

CORONARY ARTERY CALCIFICATION IN TYPE I DIABETES

Principal Investigator: Janet Snell-Bergeon
Protocol #97-661, No Longer Enrolling: 9/24/2021
Locations: Outpatient CTRC; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT00005754

Dialysis Access Data Repository

This study is designed to collect data for future investigation under the topic of perioperative care and variables affecting outcomes of dialysis access patients at UCHealth.

Principal Investigator: Lindsay Dyer-Kindy
Protocol #17-1073, No Longer Enrolling: 8/18/2021
Locations: Department Specific Free Standing Clinic; University of Colorado Hospital;

A Phase 1/2, Open-Label Safety and Dose-Finding Study of Adeno-Associated Virus (AAV) Serotype 8 (AAV8)-Mediated Gene Transfer of Human Ornithine Transcarbamylase (OTC) in Adults with Late-Onset OTC Deficiency

Principal Investigator: Janet Thomas
Protocol #16-0927, No Longer Enrolling: 8/16/2021
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT02991144

Single Patient IDE for Medtronic Vantage, IDE G170234, pt RC

Principal Investigator: Jennifer Maitlen
Protocol #20-0292, No Longer Enrolling: 2/11/2020
Location: University of Colorado Hospital;

Individual Patient Program for Patients with BRAF V600E/K mutation-positive Metastatic Melanoma and Other Indications with Clinical Evidence of Potential Treatment Efficacy Treatment with Trametinib and Bevacizumab

Principal Investigator: Nathan Dahl
Protocol #19-2412, No Longer Enrolling: 8/20/2021
Location: Childrens Hospital Colorado;

Quadriceps Tendon Autograft, Tendon-Bone versus All-Soft-Tissue for Anterior Cruciate Ligament Reconstruction: A Patient-Blinded Randomized Clinical Trial

Participants will be randomized into one of two treatment groups. In one treatment group, participants will receive the quadriceps tendon and patellar bone autograft. The second treatment group will received the all quadriceps tendon autograft. Both graft types are validated and widely used surgical approached in the pediatric and adolescent populations. We will follow participants for up to 5 years following their surgery. Participants' treatment will not differ from the normal standard of care treatment all patients receive, other than being randomized to a particular treatment group and completing questionnaires about pain and physical functioning periodically throughout treatment.

Principal Investigator: STEPHANIE MAYER
Protocol #19-1445, No Longer Enrolling: 2/28/2020
Location: Childrens Hospital Colorado;

NRG-GI005: Phase II/III Study of Circulating tumOr DNA as a Predictive BiomaRker in Adjuvant Chemotherapy in Patients with Stage IIA Colon Cancer (COBRA)

Principal Investigator: Chris Lieu
Protocol #20-0365, No Longer Enrolling: 1/8/2021
Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04068103

An open-label, randomised, multicentre, phase III study of irinotecan liposome injection, oxaliplatin, 5-fluorouracil/leucovorin versus nab-paclitaxel plus gemcitabine in subjects who have not previously received chemotherapy for metastatic adenocarcinoma of the pancreas

Principal Investigator: Alicia Deschaine
Protocol #19-6517, No Longer Enrolling: 10/16/2021
Locations: Memorial Hospital Central; Memorial Hospital North; Pikes Peak Regional Hospital;

More information available at ClinicalTrials.gov: NCT04083235

COVID-19 Biobank

Principal Investigator: Benjamin Echalier
Protocol #20-0685, No Longer Enrolling: 5/21/2021
Locations: Childrens Hospital Colorado; Department Specific Free Standing Clinic; University of Colorado Hospital;

A MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF BREXANOLONE IN THE TREATMENT OF ADOLESCENT FEMALE SUBJECTS WITH POSTPARTUM DEPRESSION

Principal Investigator: C. Neill Epperson
Protocol #19-1305, No Longer Enrolling: 4/9/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03665038

A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND ANTI TUMOR ACTIVITY OF PF-07062119 IN PATIENTS WITH ADVANCED GASTROINTESTINAL TUMORS

Principal Investigator: Andrew Hull
Protocol #19-2761, No Longer Enrolling: 11/13/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04171141

A Phase 2 randomized, placebo-controlled, double-blind, dose-ranging study evaluating LTI-01 (single-chain urokinase plasminogen activator, scuPA) in patients with infected, non-draining pleural effusions

A randomized, double-blind study, placebo-controlled, multi-center, dose-ranging study in hospitalized patients with infected, non-draining pleural effusions. LTI-01 or placebo will be administered through the vein once daily for up to 3 days to facilitate pleural (lung) fluid draining.

Principal Investigator: Ali Musani
Protocol #20-0436, No Longer Enrolling: 9/25/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04234919

The Brain Vascular Malformation Clinical Consortium (BVMC3) Project 3: Cerebral Hemorrhage Risk in Hereditary Hemorrhagic Telangiectasia

To identify genetic and circulating biomarkers of severe bleeding and predictors of brain outcomes in HHT patients. Patients will be evaluated about every 18 months for up to 10 years

Principal Investigator: Cheryl Abbott
Protocol #20-0039, No Longer Enrolling: 6/2/2020
Location: University of Colorado Hospital;

DEEP LEARNING BASED FEATURE EXTRACTION ON PANCREAS X-RAY PROJECTION IMAGES

Principal Investigator: BERNARD JONES
Protocol #19-0123, No Longer Enrolling: 6/29/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT00000000

Prescribing Practices of Psychotropic Medications by Oncology Providers at the University of Colorado Cancer Center

Principal Investigator: Elissa Kolva
Protocol #19-0181, No Longer Enrolling: 6/5/2020
Location: University of Colorado Hospital;

Identifying the Criteria that Constitute Value for Pediatric Healthcare Interventions

Principal Investigator: Melanie Whittington
Protocol #19-0779, No Longer Enrolling: 6/5/2020
;

Immunoglobulin heavy chain and T-cell receptor gamma rearrangements in acute myeloid leukemia as a potential target for minimal residual disease testing

Principal Investigator: Amanda Treece
Protocol #19-0922, No Longer Enrolling: 6/5/2020
Location: Childrens Hospital Colorado;

Lymph Node Sampling in Pediatric Renal Tumors: Survey of Current Practices and Impact of Education

Principal Investigator: Nicholas Cost
Protocol #19-0596, No Longer Enrolling: 6/5/2020
Location: Childrens Hospital Colorado;

Targeting the Regulation and Actions of Telomerase Reverse Transcriptase (TERT) in Bladder Cancer

Principal Investigator: Daniel LaBarbera
Protocol #19-1407, No Longer Enrolling: 6/5/2020
;

Impact on outcomes after omitting vincristine or vinblastine due to neuropathy in treatment of lymphoma

Principal Investigator: MANALI KAMDAR
Protocol #19-1512, No Longer Enrolling: 6/5/2020
Location: University of Colorado Hospital;

An assessment of the most commonly used medications to treat neuropathic pain in adult patients with cancer

Principal Investigator: Elizabeth Ko
Protocol #19-1517, No Longer Enrolling: 6/5/2020
Location: University of Colorado Hospital;

Multiple Distinct Vascular Neoplasms Involving IDH1 Mutations Suggest a Mosaic Pattern of Expression of IDH1 Mutants

Principal Investigator: Victor Villalobos
Protocol #19-1568, No Longer Enrolling: 6/5/2020
Location: University of Colorado Hospital;

All-patient cancer center expansion of support services (ACCESS) for tobacco cessation treatment

Principal Investigator: Arnold Levinson
Protocol #17-2279, No Longer Enrolling: 6/5/2020
Location: University of Colorado Hospital;

Ki67 as a Novel Graded Marker of Proliferative Activity in Colorectal Liver Metastasis

Principal Investigator: Ana Gleisner
Protocol #19-1799, No Longer Enrolling: 6/5/2020
Location: University of Colorado Hospital;

Adherence to follow-up recommendations after cryotherapy for high-grade cervical dysplasia

Principal Investigator: Meredith Alston
Protocol #20-0202, No Longer Enrolling: 6/5/2020
Location: Denver Health Medical Center;

Improving upon implantation and programming of directional leads in deep brain stimulation (DBS) for movement disorders

Principal Investigator: Donna Wilber
Protocol #20-0232, No Longer Enrolling: 7/14/2020
Location: University of Colorado Hospital;

Taste buds in COVID-19 patients

Principal Investigator: Kristi Engle Folchert
Protocol #20-1325, No Longer Enrolling: 7/16/2020
Location: University of Colorado Hospital;

A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Transarterial Chemoembolization (TACE) in Combination with either Durvalumab Monotherapy or Durvalumab plus Bevacizumab Therapy in Patients with Locoregional Hepatocellular Carcinoma (EMERALD-1)

Principal Investigator: Sarah Davis
Protocol #19-1342, No Longer Enrolling: 4/9/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03778957

Virtual reality in cancer patient imaging review

Principal Investigator: Sarah Milgrom
Protocol #20-0560, No Longer Enrolling: 7/7/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04469478

A Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid polyneuropathy

Principal Investigator: Dianna Quan
Protocol #19-2873, No Longer Enrolling: 7/23/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04136184

RTOG 1216 Randomized Phase II/III Trial of Adjuvant Radiation Therapy with Cisplatin, Docetaxel-Cetuximab, or Cisplatin-Atezolizumab in Pathologic High-Risk Squamous Cell Cancer of the Head and Neck

This is a clinical trial investigating the effects of the following different radiation and drug pairings of which the patient will be randomly assigned: Radiation therapy and Cisplatin(Standard of Care), Radiation therapy and Cisplatin(Investigational treatment) or Radiation therapy and Docetaxel/ Cetuximab(Investigational treatment)

Principal Investigator: Chelsea Schaefer
Protocol #14-1299, No Longer Enrolling: 2/18/2021
Locations: Lone Tree Medical Center; Memorial Hospital Central; Memorial Hospital North; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT01810913

Motor Outcomes to Validate Evaluations in FSHD

Principal Investigator: Brianna Blume
Protocol #20-0405, No Longer Enrolling: 8/5/2020
Location: University of Colorado Hospital;

EXPANSION AND EVALUATION OF THE UNIVERSITY OF COLORADO STRENGTH (STRIVING TO REACTIVATE ESOPHAGEAL AND GASTRIC HEALTH) PREHABILITATION PROGRAM

Principal Investigator: ASHLEY GLODE
Protocol #20-0246, No Longer Enrolling: 11/17/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04520867

S1815: A PHASE III RANDOMIZED TRIAL OF GEMCITABINE, CISPLATIN, AND NAB-PACLITAXEL VERSUS GEMCITABINE AND CISPLATIN IN NEWLY DIAGNOSED, ADVANCED BILIARY TRACT CANCERS

Principal Investigator: Caitlin Hutchinson
Protocol #19-1588, No Longer Enrolling: 4/7/2021
Location: Rocky Mountain Regional VA Medical Center;

More information available at ClinicalTrials.gov: NCT03768414

Radicava?/(Edaravone) Findings in Biomarkers From ALS (REFINE-ALS)

Principal Investigator: Donna Wilber
Protocol #19-1560, No Longer Enrolling: 8/18/2020
Location: University of Colorado Hospital;

A Phase 3 Study of Relacorilant in Combination with Nab-Paclitaxel in Patients with Metastatic Pancreatic Ductal Adenocarcinoma (RELIANT)

Principal Investigator: Alexis Leal
Protocol #20-0262, No Longer Enrolling: 7/21/2021
Locations: Lone Tree Medical Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04329949

Clinical Trial of Gastrostomy Button Securement Device

This is a mult-center trial where up to 200 pediatric patients will be enrolled. pediatric patients who have a gastrostomy tube placed will be eligible for enrollment and will be randomized to either receive the standard of care tic-tac-toe dressing or the new Button Huggie gastrostomy tube securement device. The patients will be followed at 4, 8, and 12 weeks after placement of the device or dressing to determine satisfaction with the device as well as post-operative outcomes.

Principal Investigator: Jenny Stevens
Protocol #18-1615, No Longer Enrolling: 9/18/2020
Locations: Childrens Hospital Colorado; Childrens Hospital Colorado at Memorial;

EA5191: A Randomized Phase II Trial of Cabozantinib and Cabozantinib Plus Nivolumab Versus Standard Chemotherapy in Patients with Previously Treated Non-Squamous NSCLC

Principal Investigator: LISA LOPEZ
Protocol #20-1737, No Longer Enrolling: 3/18/2021
Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Medical Center of the Rockies; Poudre Valley Hospital;

More information available at ClinicalTrials.gov: NCT04310007

NATURAL HISTORY STUDY OF MITOCHONDRIAL NEUROGASTROINTESTINAL ENCEPHALOMYOPATHY

Principal Investigator: Austin Larson
Protocol #20-0091, No Longer Enrolling: 10/10/2020
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT01694953

VAC31518COV3001 | A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older

There will be at least 7 study visits, over 2 years. If symptoms develop visits will be more frequent

Principal Investigator: Deina Barton
Protocol #20-2078, No Longer Enrolling: 10/16/2020
Locations: Anschutz Health and Wellness; Barbara Davis Center; Childrens Hospital Colorado; Renal Research Center;

More information available at ClinicalTrials.gov: NCT04505722

Reducing the flow from a Fontan fenestration using Atrial Flow Regulator devices - Patient QW

Principal Investigator: Gareth Morgan
Protocol #20-2505, No Longer Enrolling: 2/13/2021
Location: Childrens Hospital Colorado;

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Study Comparing the Efficacy and Safety of Tislelizumab (BGB-A317) plus Platinum and Fluoropyrimidine Versus Placebo plus Platinum and Fluoropyrimidine as First-Line Treatment in Patients with Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Principal Investigator: Sunnie Kim
Protocol #20-1346, No Longer Enrolling: 10/23/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03777657

A MULTI-CENTER, OPEN-LABEL, PHASE 2 STUDY TO EVALUATE SAFETY AND EFFICACY OF U3-1402 IN SUBJECTS WITH ADVANCED OR METASTATIC COLORECTAL CANCER (CRC)

Principal Investigator: Chris Lieu
Protocol #20-1267, No Longer Enrolling: 12/17/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04479436

ASFOTASE ALFA A Single Patient Access Treatment Plan for ASFOTASE ALFA (Human Recombinant Tissue-Nonspecific Alkaline Phosphatase Fusion Protein) Treatment for an Infant or Young Child with Hypophosphatasia (HPP)

Principal Investigator: Jennifer Barker
Protocol #15-150, No Longer Enrolling: 12/1/2020
Location: Childrens Hospital Colorado;

Single Patient IND for Nirogacestat for treatment of desmoid fibromatosis in patient DC, IND# 154034

Principal Investigator: Breelyn Wilky
Protocol #20-2809, No Longer Enrolling: 12/11/2020
Location: University of Colorado Hospital;

A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS

Principal Investigator: Ashleigh Allen
Protocol #20-0490, No Longer Enrolling: 8/18/2021
Location: Childrens Hospital Colorado;

Pre-Approval Access to Amivantamab in Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations who have Failed Platinum-Based Chemotherapy

Principal Investigator: PAULA FISK
Protocol #20-3119, No Longer Enrolling: 1/13/2021
Location: University of Colorado Hospital;

A Phase 1b, Randomized, Single-blind, Placebo-controlled, Multiple Ascending Dose (MAD) Study to Assess the Steady-State Pharmacokinetics and DQ8 Blocking Efficacy of Orally Administered IMT-002 in Patients with Type 1 Diabetes and HLA-DQ8

Principal Investigator: Hali Broncucia
Protocol #20-2220, No Longer Enrolling: 6/6/2021
Location: Barbara Davis Center;

A Phase 2a, Multicenter, Randomized, Patient and Evaluator Blinded, Controlled Study Evaluating the Safety and Efficacy of NTX-001 Compared to Standard of Care in the Treatment of Acute Single Transected Peripheral Nerve Injury Occurring below the Distal Border of the Brachial Plexus Requiring Surgical Repair

NTX-001 is a single use surgical product intended for use in conjunction with standard suture neurorrhaphy of a severed nerves in patients between 16 and 65 years of age.

Principal Investigator: Jennifer Maitlen
Protocol #20-1997, No Longer Enrolling: 10/9/2021
Locations: Denver Health and Hospital Authority; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04572906

CENTRAL VEIN SIGN: A DIAGNOSTIC BIOMARKER IN MULTIPLE SCLEROSIS

Principal Investigator: Enrique Alvarez
Protocol #20-1000, No Longer Enrolling: 3/19/2021
Locations: Brain Imaging Center (BIC); University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04495556

Pilot evaluation of COVID-19 serological conversion in MS patients

Principal Investigator: Enrique Alvarez
Protocol #21-2658, No Longer Enrolling: 3/19/2021
Location: University of Colorado Hospital;

Complicated Appendectomies

Principal Investigator: Julie Dunn
Protocol #17-6100, No Longer Enrolling: 11/20/2021
;

A Randomized, Double-Blind Phase 3 Study of Ibrutinib in Combination With Corticosteroids versus Placebo in Combination With Corticosteroids in Subjects with New Onset Chronic Graft Versus Host Disease (cGVHD)

Principal Investigator: Elizabeth Chick
Protocol #17-0396, No Longer Enrolling: 4/30/2021
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT02959944

An Open-Label Extension of Study M15-736 to Evaluate the Safety and Tolerability of 24-Hour Daily Exposure of ABBV-951 in Subjects with Advanced Parkinson's Disease

Principal Investigator: Drew Kern
Protocol #20-2130, No Longer Enrolling: 3/23/2021
Location: University of Colorado Hospital;

A Phase 3, Prospective, Multi-Center, Single-Arm, Open-Label Study to Evaluate LevoCeptTM, a Long-Acting Reversible Intrauterine System for Contraceptive Efficacy, Safety, and Tolerability

Principal Investigator: Eva Dindinger
Protocol #20-1361, No Longer Enrolling: 3/29/2021
Location: University of Colorado Hospital;

Using intraoperative microelectrode recordings to study the role of the basal ganglia in movement initiation, and movement cessation.

Principal Investigator: Daniel Kramer
Protocol #20-2979, No Longer Enrolling: 3/29/2021
Location: University of Colorado Hospital;

HERTHENA-Lung01: A Phase 2 Randomized Open-Label Study of Patritumab Deruxtecan (U3-1402) in Subjects with Previously Treated Metastatic or Locally Advanced EGFRmutated Non-Small Cell Lung Cancer (NSCLC)

Principal Investigator: Jasmine Singh
Protocol #20-2222, No Longer Enrolling: 11/19/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04619004

A PHASE 2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A SARS-COV-2 RNA VACCINE CANDIDATE (BNT162b2) AGAINST COVID-19 IN HEALTHY PREGNANT WOMEN 18 YEARS OF AGE AND OLDER

To determine the safety and efficacy of Pfizer COVID-19 vaccine in the pregnant population.

Principal Investigator: Eric Simoes
Protocol #21-2608, No Longer Enrolling: 4/9/2021
Locations: Childrens Hospital Colorado; UCHealth Internal Medical Clinic - Lowry; University of Colorado Hospital;

The influence of Weighted Blanket Therapy on Anxiety, Pain, and Restlessness in Critical and Progressive Care Patients

Principal Investigator: Holly Wiman
Protocol #21-3684, No Longer Enrolling: 9/22/2021
Location: Long's Peak Hospital;

Cohort Study of Preclinical Pulmonary Fibrosis

Principal Investigator: David Schwartz
Protocol #20-1739, No Longer Enrolling: 8/25/2021
Location: University of Colorado Hospital;

Reiki Training and Resilience in Oncology Nurses: A Mixed Methods Study

Principal Investigator: LYNNE BENTLEY
Protocol #21-3644, No Longer Enrolling: 9/22/2021
Location: University of Colorado Hospital;

A Multicenter, Randomized, Phase III Registration Trial of Transplantation of NiCord?, Ex Vivo Expanded, Umbilical Cord Blood-derived, Stem and Progenitor Cells, versus Unmanipulated Umbilical Cord Blood for Patients with Hematological Malignancies

Principal Investigator: AMY KEATING
Protocol #18-1272, No Longer Enrolling: 10/5/2021
Location: Childrens Hospital Colorado;

More information available at ClinicalTrials.gov: NCT02730299

Acceptance and Commitment Therapy for Chronic Pain in Cancer Survivors

Primary Objective: To evaluate the effectiveness of an 8-week, group-based, Acceptance and Commitment Therapy (ACT) intervention for chronic pain management in cancer survivors who have completed active treatment. Secondary Objective: To evaluate the implementation of an 8-week, group-based, ACT intervention for chronic pain management in cancer survivors who have completed active treatment.

Principal Investigator: Emily Berens
Protocol #18-1102, No Longer Enrolling: 11/12/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03661840

A Safety Study of Intravenous Infusion of Bone Marrow Mesenchymal Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for Bronchopulmonary Dysplasia

A multicenter, placebo-controlled, randomized, dose escalation, safety, and tolerability study of UNEX-42 in infants born at <27 weeks of GA at high risk for BPD

Principal Investigator: John Kinsella
Protocol #18-2881, No Longer Enrolling: 3/31/2021
Locations: Childrens Hospital Colorado; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03857841

The Role of the Autism Diagnostic Observation Schedule in the Diagnosis of Autism by a Developmental-Behavioral Pediatrician: A DBPNet Study

Principal Investigator: Sandra Friedman
Protocol #19-0382, No Longer Enrolling: 4/3/2020
Location: Childrens Hospital Colorado;

STOP BLOQ: (Surveillance and Treatment to Prevent Fetal Atrioventricular Block Likely to Occur Quickly)

While in this study you will be asked You will be asked to participate (if eligible) in three STEPS: STEP 1 – a screening step to evaluate the level of antibodies to Ro52 and Ro60 (proteins in your blood); STEP 2 – This step occurs if you are found to have high amounts of anti-Ro60 or Ro52 antibodies and involves every-other-week echos and listening to your baby’s heart beat 3x/day. The listening to the heart is called Fetal Heart Rate Monitoring (FHRM); STEP 3 – a treatment step consisting of dexamethasone and IVIG if heart block develops. This study has three purposes. The first is to find out if you have a high level of these anti-Ro/SSA antibodies in your blood which puts you at greater risk of having a baby with a heart problem. The second purpose is to find out if listening to your fetus’s heartbeat using a small Doppler device 3x/day at your home, can identify an abnormal fetal heartbeat (a slow heart rate or an irregular heart rhythm). The third purpose is to find out if urgent treatment of an abnormal fetal heartbeat can restore normal rhythm, if this abnormal heart- beat is found to be 2° heart block.

Principal Investigator: Bailey Drewes
Protocol #20-1310, No Longer Enrolling: 9/30/2021
Locations: Childrens Hospital Colorado; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04474223

Observational study of obstructive lung disease (NOVELTY): A NOVEL observational longiTudinal studY on patients with a diagnosis or suspected diagnosis of asthma and/or COPD to describe patient characteristics, treatment patterns and the burden of illness over time and to identify phenotypes and endotypes associated with differential outcomes that may support future development of personalised treatment strategies

This study is a multi-country, multicenter, observational, prospective, longitudinal cohort study which will include patients with a physician diagnosis, or suspected diagnosis, of asthma and/or COPD. Patients will undergo clinical assessments and receive standard medical care as determined by the treating physician. All patients enrolled in the NOVELTY study will be followed up yearly by their treating physician for a total duration of three years. In addition, patients are expected to be followed up remotely once every quarter.

Principal Investigator: Fernando Holguin
Protocol #17-0706, No Longer Enrolling: 12/21/2019
Location: University of Colorado Hospital;

Understanding the role of subcortical oscillations in human sleep dysregulation

Principal Investigator: John Thompson
Protocol #17-0868, No Longer Enrolling: 9/28/2021
Location: University of Colorado Hospital;

Pilot Study to Evaluate Safety and Tolerability of Inhaled N-Acetylcysteine in Pulmonary Fibrosis

This study plans to learn more about the safety and tolerability of inhaled N-Acetylcysteine (NAC) in patients with pulmonary fibrosis. We will also create a bank of data, blood, and sputum from IPF patients for future research. NAC is a medication used to loosen thick mucus. NAC was initially licensed for use in 1968. It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system, and it is available as a generic medication and is not very expensive. Inhaled NAC has been used as a mucus-dissolving therapy in respiratory conditions with excessive and/or thick mucus production.

Principal Investigator: Julie Becker
Protocol #17-1477, No Longer Enrolling: 6/30/2021
Locations: Outpatient CTRC; University of Colorado Hospital;

A Phase III, randomized, double-blind, active controlled, parallel group study, comparing the efficacy, safety and tolerability of the fixed dose combination FF/UMEC/VI with the fixed dose dual combination of FF/VI, administered once-daily via a dry powder inhaler in subjects with inadequately controlled asthma

GSK is currently developing a once-daily ?closed? triple therapy of an ICS/LAMA/LABA combination [FF/UMEC/Vilanterol (VI)] in a single device, with the aim of providing a new treatment option for the management of asthma by improving lung function, health-related quality of life (HRQoL) and symptom control over established combination therapies. Through the comparison of a closed triple therapy to a standard of care ICS/LABA combination therapy this study will provide important information to prescribers regarding the benefit of step-up to closed triple therapy to patients uncontrolled on ICS/LABA.

Principal Investigator: Fernando Holguin
Protocol #17-2041, No Longer Enrolling: 5/25/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02924688

SouthPaw: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Oral Treprostinil in Subjects with Pulmonary Hypertension (PH) in Heart Failure with Preserved Ejection Fraction (HFpEF)

This is a 24 week study to evaluate the safety of using oral treprostinil to treat PH associated with HFpEF

Principal Investigator: Cheryl Abbott
Protocol #17-0163, No Longer Enrolling: 12/3/2019
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03037580

Study of Pulmonary Rehabilitation In Nintedanib Treated Patients with IPF: Improvements in Activity, Exercise Endurance Time, and QoL

Principal Investigator: Joyce Lee
Protocol #18-2482, No Longer Enrolling: 1/6/2021
Location: University of Colorado Hospital;

A Longitudinal Study of Donor-Derived Cell Free DNA in Lung Transplant

Principal Investigator: Alice Gray
Protocol #19-2946, No Longer Enrolling: 12/2/2020
Location: University of Colorado Hospital;

Moderate to Severe Atopic Dermatitis: Evaluation of Upadacitinib in Combination with Topical Corticosteroids in Adolescent and Adult Subjects.

A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Combination with Topical Corticosteroids in Adolescent and Adult Subjects with Moderate to Severe Atopic Dermatitis

Principal Investigator: Cory Dunnick
Protocol #18-1624, No Longer Enrolling: 12/9/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03568318

A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects with Moderate to Severe Atopic Dermatitis (AD)

A Phase 2, multicenter, randomized, placebo-controlled, double-blind, parallel-group study for subjects with moderate to severe AD whose disease cannot be adequately controlled with topical medications or for whom topical treatment is medically inadvisable.

Principal Investigator: Elizabeth Wallace
Protocol #19-0144, No Longer Enrolling: 2/18/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03703102

A PHASE 3, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY OF THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN SUBJECTS WITH MILD TO MODERATE PLAQUE PSORIASIS

This study is designed to test the effectiveness of the oral drug Apremilast in patients with mild to moderate Plaque Psoriasis. The study lasts ~36 weeks (around 9 months) from start to finish for each participant. There are around 11 scheduled visits throughout the 36 weeks that participants are asked to come to the clinic to see the research team. There are treatment groups and a placebo group in this study. After the first 16 weeks of the study, everyone from the placebo group will be placed into one of the treatment groups. Please direct any further questions or inquries to the Dermatology Clinical Research Team @ 720-848-0556 or diane.ladell@cuanschutz.edu OR daniel.uy@cuanschutz.edu

Principal Investigator: Cory Dunnick
Protocol #18-2578, No Longer Enrolling: 5/2/2020
Location: University of Colorado Hospital;

The Impact of Pediatric Skin Disorders: The "Big" Study

Principal Investigator: Anna Bruckner
Protocol #18-1380, No Longer Enrolling: 6/3/2021
Location: Childrens Hospital Colorado;

A PHASE 2B/3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF PF-06651600 IN ADULT AND ADOLESCENT ALOPECIA AREATA (AA) SUBJECTS WITH 50% OR GREATER SCALP HAIR LOSS

Principal Investigator: Cory Dunnick
Protocol #18-2798, No Longer Enrolling: 2/13/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03732807

A PHASE 3 OPEN-LABEL, MULTI-CENTER, LONG-TERM STUDY INVESTIGATING THE SAFETY AND EFFICACY OF PF-06651600 IN ADULT AND ADOLESCENT PARTICIPANTS WITH ALOPECIA AREATA

Study B7981032 will investigate PF-06651600 in participants with AA. This is a Phase 3, open-label, multi-center, long-term study designed to evaluate the safety and efficacy of PF-06651600 in adults and adolescents ?12 years of age. The study will have a maximum duration of approximately 26 months. This includes up to a 5-week screening period, a 24-month open-label treatment period, and a 4-week follow-up period (See Schema). Eligible participants will be given the opportunity to enroll from the index studies B7931005 and B7981015, as well as de novo participants (ie, those who have not previously received study intervention in Study B7931005 or B7981015).

Principal Investigator: Cory Dunnick
Protocol #19-2839, No Longer Enrolling: 2/13/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04006457

A Phase 2a, Proof of Concept, 24-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-252 Cream 0.3% in Subjects with Non-Segmental Facial Vitiligo

Principal Investigator: Cory Dunnick
Protocol #20-3053, No Longer Enrolling: 7/14/2021
Locations: Outpatient CTRC; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04811131

A Multi-Center, Open-Label, Prospective Study of SpinalStim (MOP-SS) as adjunctive Care following Lumbar Fusion Surgery

The study will be a prospective, multi-center, non-randomized, single-arm clinical study to evaluate the effectiveness of SpinalStim.

Principal Investigator: Claire Cofer
Protocol #17-1037, No Longer Enrolling: 8/25/2020
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03176303

ACCUTE (AB103 Clinical Composite Endpoint Study in Necrotizing Soft Tissue Infections)

Protocol #18-6071, No Longer Enrolling: 10/2/2019
Locations: Memorial Hospital Central; Memorial Hospital North;

More information available at ClinicalTrials.gov: NCT02469857

Bedside Resources to Gauge Intravascular Volume Status in Hypovolemic Infants in the Operating Room

Principal Investigator: S Christopher Derderian
Protocol #18-2513, No Longer Enrolling: 10/9/2021
Location: Childrens Hospital Colorado;

The effect of topiramate on etonogestrel concentrations in contraceptive implant users

Principal Investigator: Eva Dindinger
Protocol #17-1047, No Longer Enrolling: 8/18/2021
Locations: Comprehensive Women's Health Center; Comprehensive Womens Health Center; University of Colorado Hospital;

A multicenter, open-label randomized study on the efficacy, cycle control and safety of a contraceptive vaginal ring delivering a daily dose of Nestorone? and estradiol (NES-E2 CVR)

Principal Investigator: Emily Graves
Protocol #18-0226, No Longer Enrolling: 11/14/2020
Locations: Comprehensive Women's Health Center; Comprehensive Womens Health Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03432416

Oral Amino Acid Nutrition to Improve Glucose Excursions in PCOS

Principal Investigator: Melanie Green
Protocol #18-0803, No Longer Enrolling: 6/10/2021
Locations: Childrens Hospital Colorado; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03717935

A multi-center, single-blind, randomized clinical trial to compare two copper IUDs:Mona Lisa NT Cu380 Mini and ParaGard

A randomized, single-blind, phase IIb/III controlled clinical trial to measure contraceptive efficacy of Mona Lisa NT Cu380 Mini. To measure contraceptive efficacy of the test product

Principal Investigator: Aaron Lazorwitz
Protocol #17-0225, No Longer Enrolling: 8/18/2021
Locations: Comprehensive Women's Health Center; Comprehensive Womens Health Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03124160

A PHASE 3, RANDOMIZED, OBSERVER-BLIND, PLACEBO-CONTROLLED, GROUP-SEQUENTIAL STUDY TO DETERMINE THE IMMUNOGENICITY AND SAFETY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) F NANOPARTICLE VACCINE WITH ALUMINUM IN HEALTHY THIRD-TRIMESTER PREGNANT WOMEN; AND SAFETY AND EFFICACY OF MATERNALLY TRANSFERRED ANTIBODIES IN PREVENTING RSV DISEASE IN THEIR INFANTS

The primary objective of this study is:  To determine the efficacy of maternal immunization with the RSV F vaccine against medically-significant RSV lower respiratory tract infection (LRTI) with EITHER hypoxemia (peripheral oxygen saturation [SpO2] < 95% at sea level or < 92% at altitudes > 1800 meters) OR tachypnea (≥ 70 bpm for infants 0 to 59 days of age or ≥ 60 bpm for infants ≥ 60 days of age) through the first 90 days of life in infants of maternal RSV F vaccinees as compared to placebo recipients. In the event that efficacy is shown through the first 90 days of life, a hierarchical sequence of hypothesis tests will be carried out to examine efficacy at 120, 150, and 180 days of life.

Principal Investigator: Christine Conageski
Protocol #18-1121, No Longer Enrolling: 1/6/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT02624947

A Phase 3, Multicenter, Open-Label Study of a Levonorgestrel 52 mg Intrauterine System for the Treatment of Heavy Menstrual Bleeding

The study is a multicenter, open-label, evaluation of the efficacy and safety of LNG20 IUS for treatment of heavy menstrual bleeding.Primary objective: Assess the efficacy of a levonorgestrel 52 mg intrauterine system (LNG20 IUS) as a treatment for heavy menstrual bleeding. Secondary objectives: Assess safety, tolerability, bleeding patterns, and continuation rates of LNG20 IUS in women using LNG20 IUS for heavy menstrual bleeding.

Principal Investigator: Emily Graves
Protocol #18-2249, No Longer Enrolling: 8/18/2021
Locations: Comprehensive Women's Health Center; Comprehensive Womens Health Center; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03642210

Vaginal/Rectal Double Swab Specimen Collection Study for use with Cepheid Xpert? GBS Assays

Cepheid is developing a rapid molecular diagnostic test for the detection of Group B Strep (GBS), a bacterial infection associated with serious illness in newborns born to women who are have a GBS infection. This study will collect specimens from pregnant women for the development of a prototype assay (laboratory test).

Protocol #18-2283, No Longer Enrolling: 10/17/2019
Location: University of Colorado Hospital;

Defining the Genetic and Cellular Causes of Human Spina Bifida

Principal Investigator: Ahmed (Rony) Marwan
Protocol #15-1141, No Longer Enrolling: 9/12/2020
Location: Childrens Hospital Colorado;

Valence and Arousal Ratings of Affective Images in Reproductive Aged Women (Females' Affective Image Ratings - FAIR Study)

If you join the study, you will participate in two study sessions, which can be completed either in-person (at Anschutz Medical Campus, in Aurora, CO) or remotely - over the internet, over the course of 2 months. The first part of the study is the screening session. During this session, the research staff will conduct an interview with you and complete questionnaires about your medical and mental health history, and your mood. The second and last part of the study is the test session. During this session, you will complete surveys about your mood, and you will rate 160 digital images. Forty of those images will be pleasant, 40 will be unpleasant, 40 will be neutral, and 40 will be erotic. You will rate these images on scales of how pleasant/unpleasant and of how arousing/non-arousing you find these images.To investigate ratings of digital images across the female menstrual cycle

Principal Investigator: Andrew Novick
Protocol #19-2872, No Longer Enrolling: 1/20/2021
Locations: Department Specific Free Standing Clinic; University of Colorado, Boulder;

Multi-center chart review of pregnant women undergoing fetoscopic laser surgery (FLS) for Twin-Twin Transfusion syndrome (TTTS) with a short cervical length.

Principal Investigator: Henry Galan
Protocol #20-0189, No Longer Enrolling: 3/23/2021
Location: Childrens Hospital Colorado;

NRG-GY021: A Phase II Randomized Trial of Olaparib Versus Olaparib Plus Tremelimumab in Platinum-Sensitive Recurrent Ovarian Cancer

Principal Investigator: Jenna Buehler
Protocol #19-2780, No Longer Enrolling: 10/20/2020
Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04034927

A Phase 1b/2, First-in-Human, Dose Escalation and Expansion Study of XMT-1536 In Patients with Solid Tumors Likely to Express NaPi2b

Principal Investigator: Bradley Corr
Protocol #20-1524, No Longer Enrolling: 10/13/2021
Locations: Outpatient CTRC; University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT03319628

A Phase 2b, Open-label, Single-arm, Multi-centre Study Assessing the Efficacy and Safety of Adavosertib as Treatment for Recurrent or Persistent Uterine Serous Carcinoma (ADAGIO)

Principal Investigator: Bradley Corr
Protocol #20-1409, No Longer Enrolling: 10/30/2021
Location: University of Colorado Hospital;

More information available at ClinicalTrials.gov: NCT04590248

Harnessing Cells from Human Milk; Linking Lactation to Metabolism

If you join the study, you will be part of the study for up to a month and a half, lasting until 2 weeks after you deliver your baby. If you decide to take part in the study, the normal care that you receive during and after pregnancy would not change. You would be asked to provide breastmilk samples and fasting blood samples and to respond to two questionnaires, which are not part of standard care during or after pregnancy. Breastfeeding protects mothers and babies against lifelong cardiometabolic disease. Unfortunately, women with obesity and diabetes struggle to make enough milk. The biology tying metabolism to milk production is not well understood because it is hard to access the human breast directly during lactation. We have made advancements in this area by describing the cells found in human milk. These closely match the milk-making cells found in the intact mammary gland. Studies in mice conducted by our group show that mammary insulin action must be carefully balanced during pregnancy and lactation. Our approach includes the study of two carefully matched groups: those with and those without recent diabetes in pregnancy. We aim to define how elevated insulin in women with recent gestational diabetes affects breast development and function. We will also look for clues that will tell us what other changes occur in the breast in response to diabetes during pregnancy. These findings will help us understand how to design treatments for mothers with obesity and/or diabetes to improve their milk supply.

Principal Investigator: Jayne Martin Carli
Protocol #21-2835, No Longer Enrolling: 11/9/2021
Location: University of Colorado Hospital;