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Novel Evaluations of Aging and Gender-Affirming Hormone Therapy on Vascular Endothelial Function and Metabolic Profiles in Transgender Women Compared to Age Group-Matched Cisgender Adults
Do you qualify? • Transgender women (i.e., assigned male at birth but identify as female) taking estradiol and spironolactone o Ages 18 to 40 or 50 to 75 years o In good general health o Have been on hormones for at least 1 year o No history of gonadectomy o...more > Protocol #: 18-2258 |
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Novel Evaluations of Aging and Gender-Affirming Hormone Therapy on Vascular Endothelial Function and Metabolic Profiles in Transgender Men Compared to Age Group-Matched Transgender Women and Cisgender Adults
Transgender men (i.e., assigned female at birth but identify as male) taking testosterone o Ages 18 to 40 or 50 to 75 years o In good general health o Have been on hormones for at least 1 year o No history of gonadectomy o No history of cancer, diabetes or heart d...more > Protocol #: 19-2323 |
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The TULIP Study - Tissue-specific mechanisms UnderLying the unique Insulin resistance Phenotype in T1D
You might be eligible if you: • Are between 20 and 45 years of age and are not obese (body mass index <30 kg/m2) • Do not have a history of cardiovascular disease (heart attack, stroke, coronary bypass surgery or angioplasty) • Are not taking statins for high cholesterol • Do not h...more > Protocol #: 19-0856 |
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A Phase 2 trial of AU-011 via suprachoroidal administration with a dose escalation phase (open-label, ascending single and repeat dose) and a randomized, masked dose expansion phase designed to evaluate the safety and efficacy of AU-011 in subjects with primary indeterminate lesions and small choroidal melanoma
This study is being conducted on patients diagnosed with a type of eye cancer called choroidal melanoma or an indeterminate lesion (a growth in your eye that is suspected to be melanoma), also known as eye melanoma. People who have choroidal melanoma are usually treated with radiation ther...more > Protocol #: 20-1186 |
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PANTHER: Puberty, diAbetes, aNd THe kidnEys, when eustress becomes distress
The study visits will be at the outpatient Clinical & Translational Research Center (CTRC) at Children’s Hospital Colorado. This study takes place over 3 years. The day 1 and day 2 visits are the same each year and will take place approx. 12 months apart. ...more > Protocol #: 21-3019 Location: Childrens Hospital Colorado |
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The Effects of Acute Resistance Exercise on Energy Balance Regulation among Breast Cancer Survivors
Exercise is important for weight management after treatment for breast cancer. This study aims to assess the effect of exercise on appetite and energy intake after breast cancer treatment. Participants will complete 3-5 study visits at the University of Colorado and receive monetary compen...more > Protocol #: 19-1974 Location: Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital |
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Non-Operative Management and Early Response Assessment in Rectal Cancer (NOM-ERA)
Non-Operative Management and Early Response Assessment in Rectal Cancer (NOM-ERA)...more > Protocol #: 20-2227 Location: Memorial Hospital Central, Memorial Hospital North |
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A Phase II, randomized, double-blind, study of the use of Rucaparib vs. placebo maintenance therapy in metastatic and recurrent endometrial cancer
This is a phase II, randomized, double-blind, trial for the use of Rucaparib as maintenance therapy in metastatic and recurrent endometrial cancer. ...more > Protocol #: 18-0567 Location: Fox Chase Cancer Center, University of Colorado Hospital, University of Pennsylvania, University of Pittsburgh Cancer Institute |
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The Intersection of Oncology Care and Worker Well-Being
You may be eligible for a research study being conducted at the University of Colorado if you are being treated for cancer and were employed when diagnosed. The WeCanWork research study at the University of Colorado Cancer Center is investigating how a new cancer diagnosis impacts wor...more > Protocol #: 21-4139 Location: Saint Joseph Hospital, University of Colorado Hospital |
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Regulatory T Cell Modulation in Kidney Transplantation with Biologic Blockade of Dual Effector Pathways, CD28 and IL-6 (CTOT-24)
CTOT-24 is a multi-center, open-label, single arm clinical trial for kidney transplant recipients. This study will evaluate a new combination of 4 anti-rejection drugs to determine if it is safe and will prevent rejection of the transplanted kidney with fewer side effects than the standard...more > Protocol #: 19-2362 Location: Outpatient CTRC, Pathology - SOM, University of Colorado Hospital |
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APOL1 Long-term Kidney Transplantation Outcomes Network
APOLLO is an observational study designed to assess the impact of RRVs in the APOL1 gene on the functional outcomes of kidneys transplanted from living and deceased donors with recent African ancestry and on the kidney function of living kidney donors with recent African ancestry in a pros...more > Protocol #: 19-0461 Location: University of Colorado Hospital |
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3CI Study: Childhood Cancer Combination Immunotherapy. Phase 1b and Expansion Study of Nivolumab Combination Immunotherapy in Children, Adolescent and Young Adult (CAYA) Patients with Relapsed/Refractory Hypermutant Cancers
TMB is the total amount of genetic changes or “mutations” found in tumor cells. Some studies in adults with cancer have shown that patients with a higher TMB are more likely to respond to immunotherapy drugs. Participants who have an elevated TMB may be eligible to take part in the treatme...more > Protocol #: 21-2688 Location: Childrens Hospital Colorado |
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The PROspera Kidney Transplant ACTIVE Rejection Assessment registry (ProActive) study
This is a non-treatment study that uses a blood test ("Prospera") to measure kidney function following transplant. This study will look at the usefulness of the Prospera testing compared to the usual serum creatinine testing done at regular intervals in kidney transplant recipients. ...more > Protocol #: 19-2394 Location: University of Colorado Hospital |
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The Lung PCA: A Multi-Dimensional Atlas of Pulmonary Premalignancy
This protocol pertains specifically to the prospective lung squamous cell carcinoma pre-malignant lesion (PML) cohort that will form a primary study group for the Lung Pre-Cancer Atlas. Via pre-screening, veteran and non-veteran subjects at high risk for the development of lung squamous c...more > Protocol #: 19-0400 Location: Rocky Mountain Regional VA Medical Center, University of Colorado Hospital |
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A Phase 3b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of TRC101 in Delaying Chronic Kidney Disease Progression in Subjects with Metabolic Acidosis
This study will compare how well the study drug works in slowing the progression of kidney disease and how safe the study drug is when compared to placebo in chronic kidney disease patients with metabolic acidosis. The average duration of the study is anticipated to be about 3.5 years. ...more > Protocol #: 18-1795 Location: Colorado Research Center, Renal Research Center |
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A Randomized, Placebo-Controlled, Phase 2 Study of HB-101, a Bivalent Cytomegalovirus (CMV) Vaccine, in CMV-Seronegative Recipient (R-) Patients Awaiting Kidney Transplantation from Living CMV-Seropositive Donors (D+)
This is a randomized, placebo-controlled, Phase 2 study of HB-101, a bivalent CMV vaccine, in CMV-seronegative recipient (R-) patients awaiting kidney transplantation from living CMV-seropositive donors (D+). The study population of the study is adult CMV seronegative (-) patients awaiting...more > Protocol #: 18-1003 Location: Outpatient CTRC, University of Colorado Hospital |
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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. ...more > Protocol #: 18-0392 Location: Highlands Ranch Hospital, Outpatient CTRC, University of Colorado Hospital |
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Effect of Alkali Therapy on Vascular and Graft Function in Kidney Transplant Recipients
Participation will last approximately 52 weeks and will include 3-7 in-person visits. Baseline, Month 6, and Month 12 visits will be held in person to assess blood vessel health. Baseline visits will be coordinated with patients' 1 year post-transplant biopsy. The Month 12 biopsy wil...more > Protocol #: 21-3447 Location: Renal Research Center, University of Colorado Hospital |
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Time Restricted Feeding in Autosomal Dominant Polycystic Kidney Disease
We want to study how feasible it is to restrict eating to 8 hours a day. Both groups will participate in a group-based, behavioral dietary intervention for 1 year (initially weekly, then monthly meetings). We will also look at changes in markers in the blood and both the size of the kidn...more > Protocol #: 20-1262 Location: Anschutz Health and Wellness, Brain Imaging Center (BIC), Renal Research Center, University of Colorado Hospital |
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EVALUATION OF PATIENT OUTCOMES FROM THE KIDNEY ALLOGRAFT OUTCOMES ALLOSURE REGISTRY (KOAR)
This is a multicenter, non-blinded, prospective observational cohort study of 1000 patients enrolled in an AlloSure testing registry, including 300 patients at centers with planned renal surveillance biopsies at 12 months post-transplantation. The other 700 patients will be from centers th...more > Protocol #: 17-2267 Location: University of Colorado Hospital |
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ULTRA-T2D Study: Uric acid lowering trial in youth onset T2D
This is a pilot study evaluating the effect of uric acid lowering by a single dose of pegloticase (a uricase) on markers of cardiovascular and renal health in ten young men ages 18-25 years with youth-onset type 2 diabetes (diagnosed at less than 21 years of age) over 7 days. Previous rese...more > Protocol #: 18-1700 Location: Childrens Hospital Colorado |
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The MAP TRIAL: PHASE III STUDY OF MUSCADINE PLUS (MPX) IN MEN WITH PROSTATE CANCER: A RANDOMIZED DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE EFFECTS OF MPX CAPSULES ON RISING PROSTATE-SPECIFIC ANTIGEN LEVELS IN ALANINE/ALANINE SOD2 GENOTYPE MEN FOLLOWING INITIAL THERAPY FOR PROSTATE CANCER
Protocol #: 18-2604 Location: University of Colorado Hospital |
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A PIVOTAL PHASE 3 TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF CLAZAKIZUMAB FOR THE TREATMENT OF CHRONIC ACTIVE ANTIBODY-MEDIATED REJECTION IN KIDNEY TRANSPLANT RECIPIENTS
This multi-center, randomized, double-blind, parallel-group, placebo-controlled, Phase 3 trial investigates whether clazakizumab (an anti-IL-6 mAb) may be beneficial for the treatment of CABMR in kidney transplant recipients by inhibiting the production of DSA and re-shaping T cell alloimm...more > Protocol #: 19-0460 Location: Outpatient CTRC, Pathology - SOM, University of Colorado Hospital |
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Inspiratory Muscle Strength Training for Lowering Systolic Blood Pressure in Midlife and Older Adults with Chronic Kidney Disease
Participants will be instructed in inspiratory muscle strength training (IMST) during baseline and will be evaluated during a 3 month period to see the effects of the device on systolic blood pressure. There will be a "placebo" arm. Participants will not know which arm they are in....more > Protocol #: 21-3000 Location: University of Colorado Hospital |
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Sex Hormone and Vascular Function in Women with CKD: A Cross-Sectional Study
This research study will compare sex hormone concentrations in healthy women to women with chronic kidney disease. We also measure blood vessel function using non-invasive testing. We are looking for: ? Women ? Aged 18-44 OR 55-75 years ? Generally healthy and free from hypertension ...more > Protocol #: 21-3018 |
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Sex Hormone and Vascular Function in Women with CKD: A Cross-Sectional Study
This research study will compare sex hormone concentrations in healthy women to women with chronic kidney disease. We also measure blood vessel function using non-invasive testing. We are looking for: ? Women ? Aged 18-44 OR 55-75 years ? Generally healthy and free from hypertension ...more > Protocol #: 21-3018 Location: University of Colorado Hospital |
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A PHASE 3 TRIAL OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE
Each study subject will be randomized to receive either study drug or placebo for a total of 100 weeks, with the exception of a 4 week period between weeks 48 an 52, where no study drug is taken. Neither the subject nor the study staff will know which treatment was given until after the st...more > Protocol #: 19-2782 Location: Brain Imaging Center (BIC), Outpatient CTRC, Renal Research Center, University of Colorado Hospital |
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The effects of cardiorespiratory fitness, physical activity and sedentary behavior on insulin resistance among breast cancer survivors being treated with anti-estrogen endocrine therapies.
Protocol #: 21-3245 Location: Anschutz Health and Wellness, Colorado State University, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital |
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AN OPEN-LABEL FEASIBILITY STUDY TO ASSESS THE SAFETY AND PHARMACOKINETICS OF ENASIDENIB IN PEDIATRIC PATIENTS WITH RELAPSED/REFRACTORY ACUTE MYELOID LEUKEMIA (R/R-AML) WITH AN ISOCITRATE DEHYDROGENASE-2 (IDH2) MUTATION
The overall goals of this study are to: - Find out what effects, good and/or bad, enasidenib has on people with your AML cancer and IDH2 mutation. - To learn more about the side effects of enasidenib The study of enasidenib in children and young adults with AML is investigational. T...more > Protocol #: 20-3065 Location: Childrens Hospital Colorado |
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eCare: Developing a virtual stress management intervention for spousal/partnered employed caregivers of solid tumor cancer patients.
Caregivers and patients must agree to participate. Caregivers are defined as people married to or partnered with cancer patients who play a role in the patient's treatment and personal care. The interventions will last 8-12 weeks and study participation will last 12 months. Caregivers in a...more > Protocol #: 20-2458 Location: Department Specific Free Standing Clinic, Kaiser Permanente of Colorado, University of Colorado Hospital |
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Human Trisome Project
Additional information about this study can be found at www.trisome.org....more > Protocol #: 15-2170 Location: Childrens Hospital Colorado, Outpatient CTRC, Outpatient CTRC, University of Colorado Hospital |
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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Phase 3 Study to Investigate the Efficacy and Safety of FInerenone, in Addition to Standard of Care, on the Progression of Kidney Disease in Patients with Non-Diabetic Chronic Kidney Disease
Trial to examine: -the impact of Finerenone vs. Placebo in delaying the progression of kidney disease. -the safety of Finerenone vs. Placebo in addition to standard of care treatment -quality of life measures via survey This trial will include 1580 participants worldwide. Stu...more > Protocol #: 21-4551 Location: Renal Research Center |
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Predictors of physical activity maintenance in colorectal cancer survivors
Supervised low to moderate intensity aerobic and resistance exercise, twice per week for 60 minutes. Four, 1-hour PA behavior change education/discussion sessions....more > Protocol #: 18-2436 |
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Predictors of physical activity maintenance in colorectal cancer survivors
Supervised low to moderate intensity aerobic and resistance exercise, twice per week for 60 minutes. Four, 1-hour PA behavior change education/discussion sessions....more > Protocol #: 18-2436 Locations: Anschutz Health and Wellness, Colorado State University, Harmony Campus, Poudre Valley Hospital, UCD Anschutz Health & Wellness Center |
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Bicarbonate Administration and Cognitive Function in Midlife and Older Adults with CKD
This study is a 52 week intervention with visits at the Renal Research Office on the University of Colorado Anschutz Medical Campus. Visits will include blood pressure checks, blood and urine collection, measurement of brain blood flow, measurement of cognitive function, and assessment...more > Protocol #: 20-1672 |
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Bicarbonate Administration and Cognitive Function in Midlife and Older Adults with CKD
This study is a 52 week intervention with visits at the Renal Research Office on the University of Colorado Anschutz Medical Campus. Visits will include blood pressure checks, blood and urine collection, measurement of brain blood flow, measurement of cognitive function, and assessment...more > Protocol #: 20-1672 Location: Renal Research Center |
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NRG-GU010: PARALLEL PHASE III RANDOMIZED TRIALS OF GENOMIC-RISK STRATIFIED UNFAVORABLE INTERMEDIATE RISK PROSTATE CANCER: DE-INTENSIFICATION AND INTENSIFICATION CLINICAL TRIAL EVALUATION (GUIDANCE)
Protocol #: 22-0175 Location: 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 |
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NRG-BR007: A PHASE III CLINICAL TRIAL EVALUATING DE-ESCALATION OF BREAST RADIATION FOR CONSERVATIVE TREATMENT OF STAGE I, HORMONE SENSITIVE, HER2-NEGATIVE, ONCOTYPE RECURRENCE SCORE <-18 BREAST CANCER
Protocol #: 21-4582 Location: Cherry Creek Medical Center, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital |
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EA8184: A Phase II Randomized Double Blinded Study of Green Tea Catechins (GTC) vs. Placebo in Men on Active Surveillance for Prostate Cancer: Modulation of Biological and Clinical Intermediate Biomarkers
Protocol #: 21-4711 Location: Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital |
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NRG-GY020: A PHASE III RANDOMIZED TRIAL OF RADIATION +/- PEMBROLIZUMAB (MK-3475) FOR NEWLY DIAGNOSED EARLY STAGE HIGH INTERMEDIATE RISK MISMATCH REPAIR DEFICIENT (dMMR) ENDOMETRIOID ENDOMETRIAL CANCER
Protocol #: 21-3887 Location: Highlands Ranch Hospital, Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital |
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EA8192: A Phase II/III trial of MEDI4736 (Durvalumab) and Chemotherapy for Patients with High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy
Protocol #: 21-3855 Location: Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital |
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S2001, Randomized Phase II Clinical Trial of Olaparib + Pembrolizumab vs. Olaparib Alone as Maintenance Therapy in Metastatic Pancreatic Cancer Patients with Germline BRCA1 or BRCA2 Mutations
Protocol #: 21-3607 Location: Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital |
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Quantification of Endo- and Phytocannabinoids and Comparison to Pain Medication Requirements for Patients Undergoing Surgery for Cancer
To determine how daily cannabis use affects surgical outcomes....more > Protocol #: 21-3544 Location: University of Colorado Hospital |
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NRG-GU009: PARALLEL PHASE III RANDOMIZED TRIALS FOR HIGH RISK PROSTATE CANCER EVALUATING DE-INTENSIFICATION FOR LOWER GENOMIC RISK AND INTENSIFICATION OF CONCURRENT THERAPY FOR HIGHER GENOMIC RISK WITH RADIATION (PREDICT-RT*)
Protocol #: 21-2970 Location: 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 |
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NRG-CC008: A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers [SOROC]
Protocol #: 20-2079 Location: Highlands Ranch Hospital, Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital |
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S1929: Phase II Randomized Study of Maintenance Atezolizumab Versus Atezolizumab Combination with Talazoparib in Patients with SLFN11 Positive Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Protocol #: 20-2084 Location: 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 |
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EA2186: A Randomized Phase II Study of Gemcitabine and Nab-Paclitaxel Compared with 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan in Older Patients with Treatment Naive Metastatic Pancreatic Cancer (GIANT)
Protocol #: 20-2150 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital |
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S1827, "A Randomized Phase III Trial of MRI Surveillance with or without Prophylactic Cranial Irradiation (PCI) in Small-Cell Lung Cancer"
Protocol #: 20-0359 Location: 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 |
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NRG-LU005: Limited Stage Small Cell Lung Cancer (LS-SCLC): A PHASE III RANDOMIZED STUDY OF CHEMORADIATION VERSUS CHEMORADIATION PLUS ATEZOLIZUMAB
Protocol #: 19-2514 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital |
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S1806: PHASE III RANDOMIZED TRIAL OF CONCURRENT CHEMORADIOTHERAPY WITH OR WITHOUT ATEZOLIZUMAB IN LOCALIZED MUSCLE INVASIVE BLADDER CANCER (Study SWOG/NRG 1806)
Protocol #: 19-1154 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital |
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CCTG MA.39 TAILOR RT: A RANDOMIZED TRIAL OF REGIONAL RADIOTHERAPY IN BIOMARKER LOW RISK NODE POSITIVE BREAST CANCER
Protocol #: 19-0476 Location: Cherry Creek Medical Center, 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 |
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LungMAP: A MASTER PROTOCOL TO EVALUATE BIOMARKER-DRIVEN THERAPIES AND IMMUNOTHERAPIES IN PREVIOUSLY-TREATED NON-SMALL CELL LUNG CANCER (Lung-MAP Screening Study)
Protocol #: 19-0267 Location: 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 |
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S1802: PHASE III RANDOMIZED TRIAL OF STANDARD SYSTEMIC THERAPY (SST) VERSUS STANDARD SYSTEMIC THERAPY PLUS DEFINITIVE TREATMENT (SURGERY OR RADIATION) OF THE PRIMARY TUMOR IN METASTATIC PROSTATE CANCER
Protocol #: 18-2252 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital |
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A021502: Randomized Trial of Standard Chemotherapy Alone or Combined with Atezolizumab as Adjuvant Therapy for Patients with Stage III Colon Cancer and Deficient DNA Mismatch Repair
Protocol #: 17-2036 Location: Greeley Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital |
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E4512 A Randomized Phase III Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib Versus Observation for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein
Protocol #: 14-1915 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital |
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PEPN2011: A Phase 1/2 Study of Tegavivint (IND#156033, NSC#826393) in Children, Adolescents, and Young Adults with Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors
For Patients on Part A: D with a solid tumor, lymphoma or desmoid tumor that has either come back or does not respond to therapy, or a desmoid tumor that cannot be removed safely by surgery. For Patients on Part B: Diagnosed with a relapsed or refractory Ewing sarcoma, desmoid tumor, os...more > Protocol #: 21-4712 Location: Childrens Hospital Colorado |
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Phase 1 Trial of Hu5F9-G4 (magrolimab) combined with dinutuximab in children and young adults with relapsed and refractory neuroblastoma or relapsed osteosarcoma
This study is being done to answer the following questions: -Is it safe to give magrolimab with dinutuximab to children, adolescents, and young adults with relapsed/refractory neuroblastoma or relapsed osteosarcoma? -What is the best dose of magrolimab to give with dinutuximab in childre...more > Protocol #: 21-3374 Location: Childrens Hospital Colorado |
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Study on the Effect of Sodium Zirconium Cyclosilicate (SZC) on Serum Potassium and Serum Bicarbonate in Patients with High Potassium and Metabolic Acidosis Due to Chronic Kidney Disease (NEUTRALIZE)
This is a 36 day trial with 8 in-person visits comparing the effect of Lokelma vs. placebo on serum potassium and bicarbonate levels. ...more > Protocol #: 21-2470 Location: Renal Research Center |
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CLINICAL TRIALS IN ORGAN TRANSPLANTATION
CTOT-21: Treg Adoptive Therapy in Subclinical Inflammation in Kidney Transplantation
This is an open label trial to determine the safety and efficacy of a single dose of autologous polyTregs in renal transplant recipients with SCI in the 3 to 7 months pos-transplant allograft biopsy compared to control patients treated with CNI-based immunosuppression. The efficacy of the ...more > Protocol #: 18-2679 Location: Outpatient CTRC, University of Colorado Hospital |
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NRG-GI004 Colorectal Cancer Metastatic dMMR Immuno-Therapy (COMMIT) Study: A Randomized Phase III Study of mFOLFOX6/Bevacizumab Combination Chemotherapy with or Without Atezolizumab or Atezolizumab Monotherapy in the First-Line Treatment of Patients with Deficient DNA Mismatch Repair (dMMR) Metastatic Colorectal Cancer
Protocol #: 18-0018 Location: 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 |
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"A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER-2 Negative Breast Cancer with Recurrence Score (RS) of 25 or Less. RxPONDER: A Clinical Trial RX for Positive Node, Endocrine Responsive Breast Cancer"
Protocol #: UCH11-1079 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital |
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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). Amendment 3 7.15.18
Protocol #: 15-1590 Location: Memorial Hospital Central, University of Colorado Hospital |
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A Phase 2a Multiple Ascending, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GFB-887, a TRPC5 Channel Inhibitor, in Patients with Diabetic Nephropathy, Focal Segmental Glomerulosclerosis, and Treatment-Resistant Minimal Change Disease
After each study subject qualifies, they will be assigned to one of the 5 treatment groups. The participants of each group will be given multiple doses of study drug at different dose levels. A computer will automatically assign the subject to one of the dose levels as well as whether the ...more > Protocol #: 20-1341 Location: University of Colorado Hospital |
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A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients with ISN/RPS 2003 Class III or IV Lupus Nephritis
After a screening period of up to 28 days, eligible subjects will be randomized to receive blinded infusions of obinutuzumab 1000 mg or placebo on Day 1, and weeks 2,24,26,50,52 in three treatment groups. and will be assessed at week 76. Neither the subject or study staff will know which t...more > Protocol #: 20-0941 Location: Outpatient CTRC, University of Colorado Hospital |
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A Multicenter, Comparative Safety and Efficacy Study of ACTHar gel alone or in combination with oral Tacrolimus to reduce urinary proteinuria in patients with idiopathic DNAJB9 Positive Fibrillary glomerulopathy
Each patient will undergo 12 months of treatment with 17 patients randomized to ACTHar gel alone (17 patients) or to ACTHar gel plus oral Tacrolimus (17 patients) Year 2: Follow up and observation for 12 months OFF ACTHar gel or ACTHar gel and Tacrolimus...more > Protocol #: 19-2902 Location: Renal Research Center, University of Colorado Hospital |
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Personalized experiences to inform improved communication for patients with Life Limiting Illness
For Aim 1, this study will test: 1) the effects on quality of communication between patient and nurse, as measured by the patient, 2) the effect of the intervention on patient’s overall biopsychosocial and spiritual well-being, as measured by the PROMIS 29 profile, and 3) the effects on pa...more > Protocol #: 19-1874 Location: University of Colorado Hospital |
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Nicotinamide riboside supplementation for treating arterial stiffness and elevated systolic blood pressure in patients with moderate to severe CKD
This is a 3 month study to determine if nicotinamide riboside (a B vitamin) will improve vascular function. During this study labs, vascular function, ambulatory BP, and office BP will be measured before taking the study drug (nicotinamide riboside/placebo) and again 3 months after daily ...more > Protocol #: 19-0149 Location: Renal Research Center, University of Colorado Hospital |
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A MULTICENTER PROSPECTIVE STUDY EVALUATING OUTCOMES OF ENDOSCOPIC ERADICATION THERAPY IN PATIENTS WITH BARRETT'S ESOPHAGUS ASSOCIATED NEOPLASIA: THE TREAT-BE (TREATMENT WITH RESECTION AND ENDOSCOPIC ABLATION TECHNIQUES FOR BARRETT'S ESOPHAGUS) CONSORTIUM
Protocol #: 14-2371 Location: Moffit Cancer Center, University of South Florida, Northwestern University, UCLA - University of California, University of Colorado Hospital, University of Kansas Cancer Center, Washington University, Siteman Cancer Center |
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ALMA: Anti Inflammatory Lipid Mediators in Asthma- A double blind, randomized, placebo controlled, crossover, proof of concept study of CXA-10 to reduce bronchial hyperresponsiveness in obese asthmatics
The main purpose of this Phase 2 double blind, placebo controlled crossover clinical study is to demonstrate the efficacy and safety of CXA-10 in obese adult asthmatics. Obesity induces a chronic systemic inflammatory state characterized by impaired adipokine signaling, pro-inflammatory cy...more > Protocol #: 19-0510 Location: Outpatient CTRC, University of Colorado Hospital, University of Pittsburgh Cancer Institute |
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A Phase 2 Study to Evaluate the Efficacy and Safety of Pembrolizumab plus Investigational Agents in Combination with Etoposide and Cisplatin or Carboplatin for the First-Line Treatment of Participants with Extensive-Stage Small Cell Lung Cancer (KEYNOTE-B99)
Protocol #: 21-3726 Location: Outpatient CTRC, University of Colorado Hospital |
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EF-36/Keynote B36: A pilot, single arm, open-label study of Tumor Treating Fields (TTFields, 150 kHz) concomitant with pembrolizumab for first line treatment of advanced or metastatic intrathoracic non-small cell lung cancer
Protocol #: 21-3694 Location: Memorial Hospital Central, Memorial Hospital North |
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A Phase 3, Randomized, Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants with Muscle-invasive Bladder Cancer (KEYNOTE-B15 / EV-304
Protocol #: 21-3677 Location: University of Colorado Hospital |
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A RANDOMIZED PHASE 3 DOUBLE-BLINDED STUDY COMPARING THE EFFICACY AND SAFETY OF NIRAPARIB TO PLACEBO IN PARTICIPANTS WITH EITHER HER2-NEGATIVE BRCA-MUTATED OR TRIPLE-NEGATIVE BREAST CANCER WITH MOLECULAR DISEASE BASED ON PRESENCE OF CIRCULATING TUMOR DNA AFTER DEFINITIVE THERAPY (ZEST)
Protocol #: 21-3616 Location: Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital |
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Detection of resistance mechanisms in cerebrospinal fluid for EGFR-mutant, ALK- and ROS1-rearranged non-small cell lung cancer patients with central nervous system (CNS) progression after evidence of prior CNS benefit on relevant tyrosine kinase inhibitors
Protocol #: 20-1193 Location: Georgetown University, University of Colorado Hospital, USC (Norris Hospital) |
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An Open-label, Phase 1b/2 Study to Evaluate the Safety and Efficacy of Fruquintinib in Combination with Tislelizumab in Patients with Advanced Solid Tumors OLD TITLE: pen-label, Phase 1b/2 Study to Evaluate the Safety and Efficacy of Fruquintinib in Combination with Tislelizumab in Patients with Advanced Triple Negative Breast Cancer
Protocol #: 21-3064 Location: Lone Tree Medical Center, University of Colorado Hospital |
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A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN328 in Patients with Advanced Cancers Associated with Expression of Delta-Like Canonical Notch Ligand 3 (DLL3) Who Have Failed Standard Available Therapy
Protocol #: 21-2992 Location: University of Colorado Hospital |
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An Open-Label, Multicenter, Non-Randomized, Dose-Confirmation and Cohort-Expansion Phase 1b Study to Evaluate the Safety, Tolerability, and Anti-Tumor Activity of ATP128, with or without BI 754091, in Patients with Stage IV Colorectal Cancer
Protocol #: 21-3062 Location: University of Colorado Hospital |
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A011801 - The CompassHER2 Trials (Comprehensive Use of Pathologic Response Assessment to Optimize Therapy in HER2-Positive Breast Cancer) CompassHER2 Residual Disease (RD), a Double-Blinded, Phase III Randomized Trial of T-DM1 Compared With T-DM1 and Tucatinib
Protocol #: 21-2558 Location: 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 |
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A PHASE 2, MULTI-COHORT, OPEN-LABEL STUDY OF INTRATUMORAL TAVOKINOGENE TELSEPLASMID PLUS ELECTROPORATION IN COMBINATION WITH INTRAVENOUS PEMBROLIZUMAB THERAPY WITH OR WITHOUT CHEMOTHERAPY IN PATIENTS WITH INOPERABLE LOCALLY ADVANCED OR METASTATIC TRIPLE NEGATIVE BREAST CANCER.
Protocol #: 20-2737 Location: Lone Tree Medical Center, University of Colorado Hospital |
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A Randomized Phase 3 Study Evaluating Cystectomy with Perioperative Pembrolizumab and Cystectomy with Perioperative Enfortumab Vedotin and Pembrolizumab versus Cystectomy Alone in Participants who are Cisplatin-Ineligible Participants or Decline Cisplatin with Muscle-Invasive Bladder Cancer (KEYNOTE-905/EV-303)
Protocol #: 20-2607 Location: Highlands Ranch Hospital, University of Colorado Hospital |
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A Phase I Dose Escalation and Dose Expansion and Phase II Monotherapy Open-label, First-in-Human, Multicenter Study of OP-1250 in Adult Subjects with Advanced and/or Metastatic Hormone Receptor (HR)-positive, HER2-negative Breast Cancer
Protocol #: 20-2279 Location: Lone Tree Medical Center, University of Colorado Hospital |
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A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF GDC-9545 COMBINED WITH PALBOCICLIB COMPARED WITH LETROZOLE COMBINED WITH PALBOCICLIB IN PATIENTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER
Protocol #: 20-0884 Location: Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital |
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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 a Fluoropyrimidine in Participants with Unresectable or Metastatic Colorectal Cancer who Have not Progressed Following First-line Induction (LYNK-003)
Protocol #: 19-6102 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital |
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Prostate oncologic therapy while ensuring neurovascular conservation (POTEN-C): a phase II randomized controlled trial of stereotactic ablative body radiotherapy (SAbR) with or without neurovascular sparing for erectile function preservation in localized prostate cancer
Protocol #: 18-2209 Location: University of Colorado Hospital |
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A Phase III Trial of Carboplatin and Paclitaxel Plus Placebo versus Carboplatin and Paclitaxel Plus Concurrent Bevacizumab (NSC #704865, IND #7921) Followed by Placebo, versus Carboplatin and Paclitaxel Plus Concurrent and Extended Bevacizumab, in Women with Newly Diagnosed, Previously Untreated, Suboptimal Advanced Stage Epithelial Ovarian and Primary Peritoneal Cancer
Protocol #: UCH06-778 Location: Greeley Campus, Harmony Campus, Medical Center of the Rockies, Poudre Valley Hospital |
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A Phase Ib/III Randomised Study of Capivasertib plus Palbociclib and Fulvestrant versus Placebo plus Palbociclib and
Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)
Protocol #: 21-3077 Location: University of Colorado Hospital |