RecruitingNCT05874921

uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto

uTRACT Jelmyto Registry: A Multicenter, Prospective and Retrospective Registry to Evaluate Real World Experience and Outcomes of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto

Sponsor

UroGen Pharma Ltd.

Enrollment

400 participants

Start Date

Nov 17, 2023

Study Type

OBSERVATIONAL

Conditions

Urothelial Carcinoma Urothelial Carcinoma of the Renal Pelvis and Ureter Urothelial Carcinoma Recurrent Carcinoma, Transitional Cell Urothelial Cancer of Renal Pelvis Urothelial Carcinoma Ureter Urothelial Carcinoma Ureter Recurrent Transitional Cell Carcinoma of Renal Pelvis

Summary

The purpose of this registry is to evaluate real world experience and outcomes of patients with Upper Tract Urothelial Cancer (UTUC) treated with Jelmyto in the United States.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a patient registry — not a treatment trial — for people with upper urinary tract cancer who have been treated with a medication called Jelmyto (mitomycin gel). The registry collects real-world data on how well the treatment works and what side effects patients experience. **You may be eligible if...** - You are an adult (over 18) and can give informed consent - You have been diagnosed with upper urinary tract cancer (urothelial cancer) - You received at least one dose of Jelmyto after it was FDA-approved (after April 15, 2020) **You may NOT be eligible if...** - You cannot give informed consent (e.g., due to dementia) - You received Jelmyto before the FDA approval date (on or before April 15, 2020) - You are pregnant or breastfeeding - You are unable to follow the study protocol requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJelmyto (mitomycin) for pyelocalyceal solution

The dose of Jelmyto to be instilled is 4 mg per mL via ureteral catheter or a nephrostomy tube, with total instillation volume based on volumetric measurements using pyelography, not to exceed 15 mL (60 mg of mitomycin). Instill Jelmyto once weekly for six weeks. For patients with a complete response 3 months after Jelmyto initiation, Jelmyto instillations may be administered once a month for a maximum of 11 additional instillations.

Locations(22)

Providence St. Johns Health Center

Santa Monica, California, United States

University of Florida

Gainesville, Florida, United States

Mount Sinai Medical Center of Florida, Inc.

Miami, Florida, United States

H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.

Tampa, Florida, United States

Northwestern University

Chicago, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

The State University of Iowa

Iowa City, Iowa, United States

Chesapeake Urology

Baltimore, Maryland, United States

Johns Hopkins Medical Center

Baltimore, Maryland, United States

Mass General Hospital (MGH)

Boston, Massachusetts, United States

The Brigham and Womens Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

University of Missouri

Columbia, Missouri, United States

Rutgers

New Brunswick, New Jersey, United States

The Feinstein Institutes for Medical Research

Lake Success, New York, United States

NYU Grossman School of Medicine

New York, New York, United States

SUNY Upstate

Syracuse, New York, United States

The University of North Carolina Chapel Hill

Chapel Hill, North Carolina, United States

Ohio State University

Columbus, Ohio, United States

Medical University of South Carolina

Charleston, South Carolina, United States

UT Southwestern Medical Center

Dallas, Texas, United States

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05874921

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