UroGen Pharma Ltd.
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.
Urothelial Carcinoma
Urothelial Carcinoma Recurrent
Urothelial Carcinoma Ureter
Urothelial Carcinoma Ureter Recurrent
Urothelial Cancer of Renal Pelvis
Urothelial Carcinoma of the Renal Pelvis and Ureter
Carcinoma, Transitional Cell
Transitional Cell Carcinoma of Renal Pelvis
Jelmyto (mitomycin) for pyelocalyceal solution
Patients may be enrolled prospectively, at the time of receiving Jelmyto, or after receiving Jelmyto for retrospective data capture and prospective follow up. Patients will be followed until 3 years after the first dose of Jelmyto or death. Data will be captured to address specific clinical questions and data gaps related to real world use of Jelmyto. Example clinical questions: 1. How is Jelmyto used in the real world setting? 2. What adverse events (AEs) and at what rates and time points are they observed in the real world setting? 3. What is the disease volume before and after resection/ablation prior to treating with Jelmyto? 4. Did the use of Jelmyto impact clinical decision making and management? 5. What is the complete response (CR) rate, duration of response, and rate of progression, including subgroups of interest? 6. What are the rates of, time to, and pathology at radical nephroureterectomy (RNU) by response to treatment and number of Jelmyto doses received? 7. What are outcomes for non-responders or partial responders? What are the rates of surgical and therapeutic treatment options received following response assessment, including additional Jelmyto? 8. What was the outcome of patients with solitary kidney and/or chronic kidney disease (CKD)? Did Jelmyto prevent dialysis by avoiding nephrectomy in solitary kidney or in patients with baseline CKD? 9. What is the rate and timing of bladder cancer occurrence and/or recurrences?
| Study Type : | OBSERVATIONAL |
| Estimated Enrollment : | 400 participants |
| Official Title : | 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 |
| Actual Study Start Date : | 2023-11-17 |
| Estimated Primary Completion Date : | 2026-04 |
| Estimated Study Completion Date : | 2028-01 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Providence St. Johns Health Center
Santa Monica, California, United States, 90404
RECRUITING
University of Florida
Gainesville, Florida, United States, 32610
RECRUITING
Mount Sinai Medical Center of Florida, Inc.
Miami, Florida, United States, 33140
RECRUITING
H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.
Tampa, Florida, United States, 33612
RECRUITING
Northwestern University
Chicago, Illinois, United States, 60611
RECRUITING
Indiana University
Indianapolis, Indiana, United States, 46202
RECRUITING
The State University of Iowa
Iowa City, Iowa, United States, 52242
RECRUITING
Chesapeake Urology
Baltimore, Maryland, United States, 21204
RECRUITING
Johns Hopkins Medical Center
Baltimore, Maryland, United States, 21287
RECRUITING
Mass General Hospital (MGH)
Boston, Massachusetts, United States, 02114
RECRUITING
The Brigham and Womens Hospital
Boston, Massachusetts, United States, 02115
RECRUITING
University of Michigan
Ann Arbor, Road cancer, United States, 48109
RECRUITING
University of Missouri
Columbia, Missouri, United States, 65211
RECRUITING
Rutgers
New Brunswick, New Jersey, United States, 08903
RECRUITING
The Feinstein Institutes for Medical Research
Lake Success, New York, United States, 11042
RECRUITING
NYU Grossman School of Medicine
New York, New York, United States, 10016
RECRUITING
SUNY Upstate
Syracuse, New York, United States, 13210
RECRUITING
The University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States, 27599
RECRUITING
Ohio State University
Columbus, Ohio, United States, 43202
RECRUITING
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
RECRUITING
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
RECRUITING
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030