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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

Upper Tract Urothelial Cancer Utuc Ugn 101 Mitomycin C Tcc Ureteral Upper Tract Carcinoma Kidney Renal Gel Local Prolonged Release Slow Release Kidney Sparing Recurrence Neoplasms By Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms By Site Antibiotics, Antineoplastic Antineoplastic Agents Alkylating Agents Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors

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.

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

0 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