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uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto
Trial Status: active
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.
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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05874921.
Locations matching your search criteria
United States
Florida
Tampa
Moffitt Cancer Center
Status: Active
Name Not Available
Illinois
Chicago
Northwestern University
Status: Active
Name Not Available
Indiana
Indianapolis
Indiana University/Melvin and Bren Simon Cancer Center
Status: Active
Name Not Available
Iowa
Iowa City
University of Iowa/Holden Comprehensive Cancer Center
Status: Approved
Name Not Available
Massachusetts
Boston
Brigham and Women's Hospital
Status: Active
Name Not Available
New Jersey
New Brunswick
Rutgers Cancer Institute of New Jersey
Status: Active
Name Not Available
New York
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Name Not Available
North Carolina
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Active
Name Not Available
Ohio
Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Name Not Available
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?