uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto
Purpose
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.
Conditions
- 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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Adults >18 years old and capable of giving informed consent. - Diagnosis of UTUC. - Receipt of at least 1 dose of JELMYTO after FDA approval (15 Apr 2020).
Exclusion Criteria
- Incapable of giving informed consent (e.g., incarcerated individuals, individuals with dementia). - Receipt of 1 or more doses of JELMYTO (also referred to as UGN-101 or Mitogel in clinical development) before FDA approval (on or before 15 Apr 2020). - Pregnancy or lactation. - Unable to comply with protocol requirements (for prospective data capture). - Any medical or mental condition(s) that makes participation in the Registry inadvisable in the opinion of the Investigator (for prospective data capture).
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Other
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Jelmyto | Patients with UTUC treated with Jelmyto |
|
Recruiting Locations
Santa Monica, California 90404
Gainesville, Florida 32610
Miami, Florida 33140
Tampa, Florida 33612
Chicago, Illinois 60611
Iowa City, Iowa 52242
Baltimore, Maryland 21287
Nirmish Singla, MD
410-955-6100
Boston, Massachusetts 02115
Columbia, Missouri 65211
Lake Success, New York 11042
New York, New York 10016
Chapel Hill, North Carolina 27599
Columbus, Ohio 43202
Charleston, South Carolina 29425
Dallas, Texas 75390
Houston, Texas 77030
More Details
- NCT ID
- NCT05874921
- Status
- Recruiting
- Sponsor
- UroGen Pharma Ltd.
Detailed Description
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?