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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Urothelial Cancer; Receptors, Fibroblast Growth Factor

Treatments: Other: Archival Tumor Tissue Sample

Study type: Observational

Funder types: Industry

Identifiers

NCT03955913

CR108627

42756493BLC0002 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 3,679 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

3,679 participants in 1 patient group

Participants with Urothelial Cancer,selected FGFR aberrations

Description:

Participants with urothelial cancer (UC) will be evaluated for the prevalence of positive results of selected fibroblast growth factor receptor (FGFR) aberrations and will be assessed for eligibility status for erdafitinib studies. The primary data source for this study will be the medical records of each participant.

Treatment:

Other: Archival Tumor Tissue Sample