uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) 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
UroGen Pharma Ltd.
400 participants
Nov 17, 2023
OBSERVATIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria5
- 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).
Interventions
The dose of Jelmyto to be instilled is 4 mg per mL via ureteral catheter or a nephrostomy tube, with total instillation volume based on volumetric measurements using pyelography, not to exceed 15 mL (60 mg of mitomycin). Instill Jelmyto once weekly for six weeks. For patients with a complete response 3 months after Jelmyto initiation, Jelmyto instillations may be administered once a month for a maximum of 11 additional instillations.
Locations(22)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05874921