NCT05874921 uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto
| NCT ID | NCT05874921 |
| Status | Recruiting |
| Phase | — |
| Sponsor | UroGen Pharma Ltd. |
| Condition | Urothelial Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2023-11-17 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2023-11-17 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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).
Contact & Investigator
Yair Lotan, MD
PRINCIPAL INVESTIGATOR
UT Southwestern Medical Center at Dallas
Frequently Asked Questions
Who can join the NCT05874921 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Urothelial Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05874921 currently recruiting?
Yes, NCT05874921 is actively recruiting participants. Contact the research team at registry@urogen.com for enrollment information.
Where is the NCT05874921 trial being conducted?
This trial is being conducted at Santa Monica, United States, Gainesville, United States, Miami, United States, Tampa, United States and 11 additional locations.
Who is sponsoring the NCT05874921 clinical trial?
NCT05874921 is sponsored by UroGen Pharma Ltd.. The principal investigator is Yair Lotan, MD at UT Southwestern Medical Center at Dallas. The trial plans to enroll 400 participants.