Actively Recruiting
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
Led by UroGen Pharma Ltd. · Updated on 2025-02-28
400
Participants Needed
22
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating real-world experiences and outcomes of patients with Upper Tract Urothelial Cancer (UTUC) who receive Jelmyto treatment in the United States. This registry collects both past and ongoing patient data to understand how Jelmyto is used outside of clinical trials and to address important clinical questions about its effects and safety. Participants receive Jelmyto, a drug administered via ureteral catheter or nephrostomy tube, with a dose of 4 mg per mL not exceeding 15 mL per instillation. Jelmyto is given once weekly for six weeks initially. If patients show a complete response three months after starting treatment, they may receive monthly instillations for up to 11 additional doses. Patients can be enrolled either when starting Jelmyto or retrospectively after treatment to allow prospective follow-up. Throughout the study, patients are followed for up to three years or until death after their first Jelmyto dose. Data collected include treatment usage, adverse events, disease status before and after surgery, response rates, progression, and outcomes for those with kidney issues. Researchers also track surgery rates, additional treatments, bladder cancer recurrence, and how Jelmyto affects clinical decisions. The main outcome measured is the rate of complete response or no evidence of disease three months after treatment begins.
CONDITIONS
Brief Title
uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults over 18 years old able to give informed consent
- Diagnosis of Upper Tract Urothelial Cancer (UTUC)
- Received at least one dose of Jelmyto after FDA approval date (April 15, 2020)
You will not qualify if you...
- Unable to give informed consent (e.g., incarcerated individuals, individuals with dementia)
- Received one or more doses of Jelmyto before FDA approval date (on or before April 15, 2020)
- Pregnancy or lactation
- Unable to comply with study protocol requirements (for prospective data capture)
- Any medical or mental condition making participation inadvisable as judged by the Investigator (for prospective data capture)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Duration - Initial 6 weeks plus up to 11 additional months for responders
Participants receive Jelmyto instillations once weekly for six weeks. If a complete response is observed 3 months after starting Jelmyto, participants may receive additional monthly instillations for up to 11 months.
Weekly visits for 6 weeks, then monthly visits for up to 11 months depending on response
Duration - Up to 3 years
Participants are followed for up to 3 years after the first dose of Jelmyto to capture data on response duration, progression, adverse events, and other outcomes.
Follow-up visits scheduled as per routine clinical care for up to 3 years
Trial Site Locations
Total: 22 locations
1
Providence St. Johns Health Center
Santa Monica, California, United States, 90404
Actively Recruiting
2
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
3
Mount Sinai Medical Center of Florida, Inc.
Miami, Florida, United States, 33140
Actively Recruiting
4
H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.
Tampa, Florida, United States, 33612
Actively Recruiting
5
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
6
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
7
The State University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
8
Chesapeake Urology
Baltimore, Maryland, United States, 21204
Actively Recruiting
9
Johns Hopkins Medical Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
10
Mass General Hospital (MGH)
Boston, Massachusetts, United States, 02114
Actively Recruiting
11
The Brigham and Womens Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
12
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
13
University of Missouri
Columbia, Missouri, United States, 65211
Actively Recruiting
14
Rutgers
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
15
The Feinstein Institutes for Medical Research
Lake Success, New York, United States, 11042
Actively Recruiting
16
NYU Grossman School of Medicine
New York, New York, United States, 10016
Actively Recruiting
17
SUNY Upstate
Syracuse, New York, United States, 13210
Actively Recruiting
18
The University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
19
Ohio State University
Columbus, Ohio, United States, 43202
Actively Recruiting
20
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
21
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
22
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
M
Michael Louie, MD, MPH, MSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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