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

Completed

• Conditions: Urothelial Cancer; Receptors, Fibroblast Growth Factor

• Registration Number: NCT03955913
• Lead Sponsor: Janssen Research & Development, LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-17
• Study First Submitted QC: 2019-05-17
• Study First Posted: 2019-05-20
• Study Start: 2019-08-01
• Primary Completion: 2022-09-19
• Study Completion: 2022-09-19
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-23
• Last Update Posted: 2023-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3679

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations	Up to 3.9 years	Percentage of participants with selected FGFR gene aberrations will be assessed through molecular testing of their archival tumor tissue.

Trial Locations

Locations (199)

Arizona Oncology Associates, PC - HOPE; 🇺🇸 Tucson, Arizona, United States

Rocky Mountain Cancer Centers; 🇺🇸 Denver, Colorado, United States

Medical Oncology Hematology Consultants, PA; 🇺🇸 Newark, Delaware, United States

Affiliated Oncologists, LLC; 🇺🇸 Chicago Ridge, Illinois, United States

Maryland Oncology Hematology, PA; 🇺🇸 Brandywine, Maryland, United States

Minnesota Oncology Hematology, P.A.; 🇺🇸 Minneapolis, Minnesota, United States

New York Oncology Hematology; 🇺🇸 Albany, New York, United States

Broome Oncology; 🇺🇸 Johnson City, New York, United States

Oncology Hematology Care; 🇺🇸 Cincinnati, Ohio, United States

Willamette Valley Cancer Institute and Research Center; 🇺🇸 Eugene, Oregon, United States

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