Biomarker Study to Identify Subjects With Urothelial Cancer and Fibroblast Growth Factor Receptor Gene Aberrations

Janssen Research & Development, LLC199 sites in 4 countries3,679 target enrollmentAugust 1, 2019

ConditionsUrothelial Cancer Receptors, Fibroblast Growth Factor

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Urothelial Cancer
Sponsor: Janssen Research & Development, LLC
Enrollment: 3679
Locations: 199
Primary Endpoint: Percentage of Participants with Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

August 1, 2019

End Date

September 19, 2022

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Janssen Research & Development, LLC

Responsible Party

Sponsor

Eligibility Criteria

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