In-Utero Vascular Accidents in Neonates from COVID-19 Infected MothersThis study plans to learn more about how COVID-19 infection during pregnancy may have direct effects on the developing baby 30 days after birth. Protocol #: 20-1399 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
A Phase 2A, Double-blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Saroglitazar Magnesium 4 mg Tablets for Treating Nonalcoholic Fatty Liver Disease (NAFLD) in Women With Polycystic Ovary Syndrome (PCOS)Protocol #: 20-0589 Location: University of Colorado Hospital |
Role of Kv7 channels in the regulation of placental arteries vasoreactivity in mothers with Long QT syndrome (LQTS) Types 1 and 2Protocol #: 20-0226 Location: Childrens Hospital Colorado |
Multi-center chart review of pregnant women undergoing fetoscopic laser surgery (FLS) for Twin-Twin Transfusion syndrome (TTTS) with a short cervical length.Protocol #: 20-0189 Location: Childrens Hospital Colorado |
ENGOT-ov50 / INNOVATE-3: Pivotal, Randomized, Open-Label Study of Tumor Treating Fields (TTFields, 200kHz) Concomitant with Weekly Paclitaxel for the Treatment of Recurrent Ovarian CancerProtocol #: 20-0007 Location: University of Colorado Hospital |
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 Protocol #: 19-2872 Locations: Department Specific Free Standing Clinic; University of Colorado, Boulder |
NRG-GY019: A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients With Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or PeritoneumProtocol #: 19-2797 Location: University of Colorado Hospital |
LIO-1: A Phase 1b/2, Open-Label Study to Evaluate the Safety and Efficacy of Lucitanib in Combination With Nivolumab in Patients With An Advanced, Metastatic Solid TumorProtocol #: 19-2795 Location: University of Colorado Hospital |
A Phase 2 Study of Olaparib Monotherapy in Participants with Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced CancerProtocol #: 19-2640 Location: Rocky Mountain Regional VA Medical Center |
Feasibility and Limited Efficacy Trial of a Cognitive Behavioral Intervention to Reduce Procedural Anxiety Among Woman with High Risk Pregnancies with Scheduled Cesarean DeliveriesProtocol #: 19-1896 Location: Childrens Hospital Colorado |
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 CancerProtocol #: 19-2311 Location: University of Colorado Hospital |
Role of vascular/cardiac biomarkers in amniotic fluid of patients with Twin-Twin Transfusion Syndrome (TTTS)Protocol #: 14-1413 Location: Childrens Hospital Colorado |
NAFTNet Prenatal Diagnosis of Isolated Aqueductal StenosisProtocol #: 18-1076 Location: Childrens Hospital Colorado |
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 cancerProtocol #: 19-1977 Location: University of Colorado Hospital |
A Phase 1a/b Dose-Finding Escalation Study Followed by Expansion Cohorts of NGM120, a GFRAL Antagonist Monoclonal Antibody Blocking GDF15 Signaling, in Subjects With Advanced Solid Tumors and Pancreatic Cancer Using Combination TherapyProtocol #: 19-1458 Location: University of Colorado Hospital |
A Phase 2, Multi-arm, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of IPI-549 Administered in Combination with Front-line Treatment Regimens in Patients with Locally Advanced and/or Metastatic Triple-Negative Breast Cancer or Renal Cell Carcinoma.Protocol #: 19-1337 Locations: Lone Tree Medical Center; University of Colorado Hospital |
NRG-BR004: A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast CancerProtocol #: 19-1152 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 |
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 cancerProtocol #: 19-6076 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital |
A Phase 1, Open Label, Dose-Escalation and Expansion Study of Oral ORIN1001 with and without Chemotherapy in the Treatment of Subjects with Solid TumorsProtocol #: 19-1118 Locations: Highlands Ranch Hospital; Lone Tree Medical Center; University of Colorado Hospital |
A Phase 1, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of PSB205 in Patients with Relapsed/Refractory Solid TumorsProtocol #: 19-1069 Location: University of Colorado Hospital |
A Phase 1/2 First-in-human Study of BMS-986288 Alone and in Combination with Nivolumab in Advanced Malignant TumorsProtocol #: 19-0604 Location: University of Colorado Hospital |
Treating PCOS with Semaglutide vs Active Lifestyle Intervention (TEAL Study)The study consists of an initial study visit to determine eligibility, 2 inpatient visits (one prior to starting treatment and one at the end of the 4 month treatment intervention), and one short visit midway between the study. Protocol #: 19-0636 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
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 tumorsProtocol #: 19-0556 Locations: Lone Tree Medical Center; University of Colorado Hospital |
A large-scale multicenter phase II study evaluating the protective effect of a tissue selective estrogen complex (TSEC) in women with newly diagnosed ductal carcinoma in situ.Protocol #: 19-0632 Locations: Highlands Ranch Hospital; Lone Tree Medical Center; University of Colorado Hospital |
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)Protocol #: 19-0507 Location: University of Colorado Hospital |
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 CancerProtocol #: 19-0457 Location: University of Colorado Hospital |
CCTG MA.39 TAILOR RT: A RANDOMIZED TRIAL OF REGIONAL RADIOTHERAPY IN BIOMARKER LOW RISK NODE POSITIVE BREAST CANCERProtocol #: 19-0476 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
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 TumorsProtocol #: 19-0207 Location: University of Colorado Hospital |
A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination in Women with ER-positive, HER2 negative Advanced Breast Cancer (SERENA-1)Protocol #: 18-2654 Location: University of Colorado Hospital |
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 THERAPYProtocol #: 18-2569 Location: University of Colorado Hospital |
A Phase 3, Multicenter, Open-Label Study of a Levonorgestrel 52 mg Intrauterine System for the Treatment of Heavy Menstrual BleedingThe 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. Protocol #: 18-2249 Locations: Comprehensive Women's Health Center; Comprehensive Womens Health Center; University of Colorado Hospital |
Open Label Phase 2 Study of Tisotumab Vedotin for Patients with Platinum-Resistant Ovarian Cancer with a Safety Run-in of a Dose-Dense RegimenProtocol #: 18-6061 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies |
A Phase 1, Open-Label, Multicenter, Dose Escalation Study of mRNA-2752, a Lipid Nanoparticle Encapsulating mRNAs Encoding Human OX40L, IL-23, and IL-36, for Intratumoral Injection Alone and in Combination with Immune Checkpoint BlockadeProtocol #: 18-1526 Location: University of Colorado Hospital |
Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid TumorsProtocol #: 18-6055 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital |
A Phase 1, Open-Label, Multicenter, Dose-Escalation Study of RMC-4630 Monotherapy in Adult Participants with Relapsed/Refractory Solid Tumors. Protocol v.1.3Protocol #: 18-1150 Location: University of Colorado Hospital |
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 INFANTSThe 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. Protocol #: 18-1121 Location: University of Colorado Hospital |
RT CHARM: PHASE III RANDOMIZED TRIAL OF HYPOFRACTIONATED POST MASTECTOMY RADIATION WITH BREAST RECONSTRUCTIONProtocol #: 18-0627 Locations: Memorial Hospital Central; Memorial Hospital North; University of Colorado Hospital |
A Randomized Controlled Trial of Ultrasonic Aspiration versus CO2 Laser Ablation for the Treatment of Vulvar Intraepithelial NeoplasiaThe primary objective of this study is to evaluate the incidence of vulva dysplasia recurrence within 12 months of treatment with CO2 laser ablation or ultrasonic aspiration. Women referred for treatment following diagnosis of VIN II/III will be randomized to receive CO2 laser ablation (typical treatment for these cases) or ultrasonic aspiration (approved treatment providing a more targeted technique). Secondary objectives will examine incidences of pain, scarring, and sexual and psychosocial distraught following treatment for high-grade dysplasia. Protocol #: 16-0701 Locations: Denver Health Medical Center; University of Colorado Hospital; University of Oklahoma |
A multi-center, single-blind, randomized clinical trial to compare two copper IUDs:Mona Lisa NT Cu380 Mini and ParaGardA 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 Protocol #: 17-0225 Locations: Comprehensive Women's Health Center; Comprehensive Womens Health Center; University of Colorado Hospital |
Oral Amino Acid Nutrition to Improve Glucose Excursions in PCOSProtocol #: 18-0803 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
A Phase II, randomized, double-blind, study of the use of Rucaparib vs. placebo maintenance therapy in metastatic and recurrent endometrial cancerThis is a phase II, randomized, double-blind, trial for the use of Rucaparib as maintenance therapy in metastatic and recurrent endometrial cancer. Protocol #: 18-0567 Locations: Fox Chase Cancer Center; University of Colorado Hospital; University of Pennsylvania |
PLACENTAL PROTEINS AND PREMATURITY (P3 STUDY)This study plans to learn more about why babies born prematurely sometimes can have problems with infections, breathing, feeding, vision, and brain function. Protocol #: 18-0637 Location: University of Colorado Hospital |
Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Right and Left Congenital Diaphragmatic Hernia (CDH)Protocol #: 18-0461 Location: Childrens Hospital Colorado |
Combining Testosterone Therapy and Exercise to Improve Function Post Hip FractureProtocol #: 17-2186 Location: University of Colorado Hospital |
EA1151: Tomosynthesis Mammographic Imaging Screening Trial (TMIST)Participants in this trial will be randomized to receive either 2D or 3D mammograms for the first 5 years of the research study, either ever year or every other year depending on personal risk factors. Information will be collected on breast cancer status for 8 years in total. To compare the proportions of participants in the Tomosynthesis (TM) and Digital Mammography (DM) study arms experiencing the occurrence of an advanced breast cancer at any time during a period of 4.5 years from randomization, including the period of active screening and a period of clinical follow-up after the last screen (T4). To assess the potential effect of age, menopausal and hormonal status, breast density, and family cancer history on the primary endpoint difference between the two arms. Protocol #: 18-0392 Locations: Highlands Ranch Hospital; 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)Protocol #: 18-0226 Locations: Comprehensive Women's Health Center; Comprehensive Womens Health Center; University of Colorado Hospital |
A Phase 1b/2a Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination with AvelumabProtocol #: 18-0187 Location: University of Colorado Hospital |
A Phase 1/2 First-in-human Study of BMS-986258 Alone and in Combination with Nivolumab in Advanced Malignant TumorsProtocol #: 18-0031 Locations: Lone Tree Medical Center; University of Colorado Hospital |
Amniotic Fluid-Derived Cardiomyocyte Model to Investigate Mechanotransduction in CardiomyocytesProtocol #: 17-2296 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
Assessment of NAAT to Determine GBS Status After Initiation of Intrapartum Antibiotic ProphylaxisThis study plans to learn more about a new method of testing for GBS, to see if it can be reliably used after antibiotics have been started. Protocol #: 17-2177 Location: University of Colorado Hospital |
Electronic Cigarette Use During PregnancyProtocol #: 17-2033 Locations: CU John C. Hobbins Perinatal Center; CU Parker Perinatal Center; Denver Health Medical Center; Department Specific Free Standing Clinic; University of Colorado Hospital |
The effect of topiramate on etonogestrel concentrations in contraceptive implant usersProtocol #: 17-1047 Locations: Comprehensive Women's Health Center; Comprehensive Womens Health Center; University of Colorado Hospital |
A Phase IA/IB Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of RO7198457 as a Single Agent and in Combination with Atezolizumab in Patients with Locally Advanced or Metastatic TumorsProtocol #: 17-0991 Locations: Lone Tree Medical Center; University of Colorado Hospital |
A Pragmatic Multicenter Randomized Trial: Antihypertensive Therapy for Mild Chronic Hypertension During Pregnancy (CHAP Project)Protocol #: 17-0914 Locations: Denver Health Medical Center; University of Colorado Hospital |
Effects of high altitude on AMPK activationThis study plans to learn more about differences in pregnancy between high and low altitudes in Colorado. Participants will be asked to complete ultrasounds and provide blood samples throughout pregnancy, and provide samples such as cord blood at the time of delivery. Protocol #: 14-2178 Locations: CTRC-perinatal; CU John C. Hobbins Perinatal Center; University of Colorado Hospital |
S1609, DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare TumorsProtocol #: 17-0280 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
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 MalignanciesProtocol #: 17-0074 Locations: Lone Tree Medical Center; University of Colorado Hospital |
A PHASE 1, DOSE ESCALATION STUDY OF ALX148 IN PATIENTS WITH ADVANCED SOLID TUMORS AND LYMPHOMAProtocol #: 16-2248 Locations: Lone Tree Medical Center; University of Colorado Hospital |
Double-blind Trial of Phosphatidylcholine Supplementation during Pregnancy: Impact on Attention and Social Withdrawal at 4 years of AgeProtocol #: 16-1510 Locations: Colorado Research Center; Denver Health Medical Center; Department Specific Free Standing Clinic; University of Colorado Hospital |
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 CancerProtocol #: 16-0493 Locations: Lone Tree Medical Center; University of Colorado Hospital |
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 RearrangementProtocol #: 15-1574 Location: University of Colorado Hospital |
EAY131 Molecular Analysis for Therapy Choice (MATCH)Protocol #: 15-1111 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
Total Cancer Care Protocol: A Lifetime Partnership with Patients Who Have or May be at Risk of Having Cancer (ORIEN)Protocol #: 15-1110 Locations: Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
PT-112-101 A Phase I, Open-Label, Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-122 Injection in Subjects with Advanced Solid TumorsThis is a clinical trial of PT-112 that will be administered injection which is investigational. Protocol #: 14-0151 Location: University of Colorado Hospital |