Registry of patients with upper tract urothelial cancer treated with Jelmyto

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This registry aims to evaluate the real-world experiences and outcomes of patients diagnosed with upper tract urothelial cancer (UTUC) who are treated with Jelmyto. Patients can be enrolled either prospectively at the time of receiving Jelmyto or retrospectively after treatment, with follow-up extending up to three years post-treatment. The registry will collect data to address various clinical questions regarding the use of Jelmyto, including its effectiveness, adverse events, and impact on clinical decision-making.

Why it matters

Who can join: the full rules

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).

Where it's running

• Providence St. Johns Health Center
  Santa Monica, California, United States Recruiting
• University of Florida
  Gainesville, Florida, United States Recruiting
• Mount Sinai Medical Center of Florida, Inc.
  Miami, Florida, United States Recruiting
• H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.
  Tampa, Florida, United States Recruiting
• Northwestern University
  Chicago, Illinois, United States Recruiting
• Indiana University
  Indianapolis, Indiana, United States Recruiting

Study contacts

• Principal investigator: Yair Lotan, MD — UT Southwestern Medical Center at Dallas
• Study coordinator: Michael Louie, MD, MPH, MSc
• Email: registry@urogen.com
• Phone: 855-987-6436

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.