CompletedNot Applicable

A Study to Identify Participants With Urothelial Cancer and Fibroblast Growth Factor Receptor Gene Aberrations

United States3,679 participantsStarted 2019-08-01

Plain-language summary

The purpose of this non-interventional study is to identify participants with urothelial cancer (UC) and selected fibroblast growth factor receptor (FGFR) aberrations through molecular testing of their archival tumor tissue.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Transitional cell carcinoma of the urothelium. Urothelial cell carcinoma (UCC) variants are allowed, that is, UCC with squamous and/or glandular differentiation, micropapillary, nested, plasmacytoid, neuroendocrine, and sarcomatoid * Diagnosis of one of the following: a) Metastatic or surgically unresectable urothelial cancer (UC) (Stage IV) or, b) localized surgically-resectable or resected UC with a T classification of T2 or above or non-muscle-invasive urothelial carcinoma of the bladder (Ta, T1 and carcinoma in situ \[CIS\]) * Available archival tissue sample for fibroblast growth factor receptor (FGFR) aberration analysis Exclusion Criteria: \-

What they're measuring

Percentage of Participants with Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations

Timeframe: Up to 3.9 years

Trial details

NCT IDNCT03955913

SponsorJanssen Research & Development, LLC

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-09-19

View on ClinicalTrials.gov More Urothelial Cancer trials