Registry Study to Evaluate Real World Use and Outcomes of Jelmyto Treatment in Adults with Upper Tract Urothelial Cancer

What this Trial Is About

Researchers are evaluating real-world experiences and outcomes of patients with Upper Tract Urothelial Cancer UTUC who receive Jelmyto treatment in the United States. This registry collects both past and ongoing patient data to understand how Jelmyto is used outside of clinical trials and to address important clinical questions about its effects and safety. Participants receive Jelmyto, a drug administered via ureteral catheter or nephrostomy tube, with a dose of 4 mg per mL not exceeding 15 mL per instillation. Jelmyto is given once weekly for six weeks initially. If patients show a complete response three months after starting treatment, they may receive monthly instillations for up to 11 additional doses. Patients can be enrolled either when starting Jelmyto or retrospectively after treatment to allow prospective follow-up. Throughout the study, patients are followed for up to three years or until death after their first Jelmyto dose. Data collected include treatment usage, adverse events, disease status before and after surgery, response rates, progression, and outcomes for those with kidney issues. Researchers also track surgery rates, additional treatments, bladder cancer recurrence, and how Jelmyto affects clinical decisions. The main outcome measured is the rate of complete response or no evidence of disease three months after treatment begins.

uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto