Registry of patients with upper tract urothelial cancer treated with Jelmyto
uTRACT Jelmyto Registry: A Multicenter, Prospective and Retrospective Registry to Evaluate Real World Experience and Outcomes of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto
This study is looking at how well Jelmyto works for people with upper tract urothelial cancer by tracking their experiences and outcomes over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UroGen Pharma Ltd. Industry-sponsored |
| Locations | 22 sites (Santa Monica, California and 21 other locations) |
| Trial ID | NCT05874921 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this registry are adults over 18 years old who have been diagnosed with upper tract urothelial cancer and have received at least one dose of Jelmyto after its FDA approval.
Not a fit: Patients who received Jelmyto before its FDA approval or those unable to provide informed consent may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the effectiveness and safety of Jelmyto for treating UTUC, potentially improving patient management.
How similar studies have performed: While this registry approach is not novel, it builds on existing data collection methods for cancer treatments, and similar studies have shown success in evaluating real-world treatment outcomes.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Santa Monica, California and 21 other locations
- 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)
- The State University of Iowa — Iowa City, Iowa, United States (Recruiting)
- Chesapeake Urology — Baltimore, Maryland, United States (Recruiting)
- Johns Hopkins Medical Center — Baltimore, Maryland, United States (Recruiting)
- Mass General Hospital (MGH) — Boston, Massachusetts, United States (Recruiting)
- The Brigham and Womens Hospital — Boston, Massachusetts, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- University of Missouri — Columbia, Missouri, United States (Recruiting)
- Rutgers — New Brunswick, New Jersey, United States (Recruiting)
- The Feinstein Institutes for Medical Research — Lake Success, New York, United States (Recruiting)
- NYU Grossman School of Medicine — New York, New York, United States (Recruiting)
- SUNY Upstate — Syracuse, New York, United States (Recruiting)
- The University of North Carolina Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
- Ohio State University — Columbus, Ohio, United States (Recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
- UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
- The University of Texas M.D. Anderson Cancer Center — Houston, Texas, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.