uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto
Launched by UROGEN PHARMA LTD. · May 22, 2023
Trial Information
Current as of July 04, 2025
Recruiting
Keywords
ClinConnect Summary
The uTRACT Jelmyto Registry is a clinical study designed to gather information about patients with Upper Tract Urothelial Cancer (UTUC) who are being treated with a medication called Jelmyto. This registry aims to understand how well Jelmyto works in real-life situations and how it affects patients' health outcomes. It is currently recruiting patients in the United States, and anyone aged 65 and older diagnosed with UTUC may be eligible to participate, especially if they have been treated with Jelmyto since April 2020, are currently receiving it, or are planned to start treatment soon.
Participants in this study will have the opportunity to share their experiences and health results while being treated with Jelmyto, helping doctors learn more about this treatment. There are no specific exclusions, so if someone meets the age and diagnosis criteria, they can take part. This is an important step in improving our understanding of UTUC and could help future patients with similar conditions.
Gender
ALL
Eligibility criteria
- 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).
About Urogen Pharma Ltd.
Urogen Pharma Ltd. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for urological diseases, with a particular emphasis on bladder cancer and other disorders affecting the urinary tract. Leveraging advanced drug delivery technologies and a robust pipeline of product candidates, Urogen aims to address unmet medical needs and improve patient outcomes. The company is committed to conducting rigorous clinical trials, adhering to the highest standards of scientific integrity and regulatory compliance, while fostering collaborations with healthcare professionals and research institutions to drive advancements in urology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Ann Arbor, Michigan, United States
Charleston, South Carolina, United States
Indianapolis, Indiana, United States
Gainesville, Florida, United States
Dallas, Texas, United States
Houston, Texas, United States
Baltimore, Maryland, United States
Syracuse, New York, United States
Columbia, Missouri, United States
Columbus, Ohio, United States
Boston, Massachusetts, United States
Miami, Florida, United States
New Brunswick, New Jersey, United States
New York, New York, United States
Tampa, Florida, United States
Baltimore, Maryland, United States
Santa Monica, California, United States
Iowa City, Iowa, United States
Boston, Massachusetts, United States
Lake Success, New York, United States
Chapel Hill, North Carolina, United States
Patients applied
Trial Officials
Yair Lotan, MD
Principal Investigator
UT Southwestern Medical Center at Dallas
Adam Feldman, MD
Principal Investigator
Massachusett's General Hospital
Solomon Woldu, MD
Principal Investigator
UT Southwestern Medical Center at Dallas
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported