uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) Treatedā¦ (NCT05874921) | Clinical Trial Compass
RecruitingNot Applicable
uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto
United States400 participantsStarted 2023-11-17
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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).
What they're measuring
1
Rate of CR or no evidence of disease (NED) at first evaluation post-treatment