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

Completed

Conditions studied: Urothelial Cancer, Receptors, Fibroblast Growth Factor

In brief

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.

Key facts

Study ID

NCT03955913

Run by

Janssen Research & Development, LLC

People needed

3679

Starts

2019-08-01

Expected to finish

2022-09-19

Last updated by the study team

2023-02-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• 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
• Northwest Cancer Specialists PC — Tualatin, Oregon, United States
• Consultants in Medical Oncology and Hematology, P.C. - Abington — Horsham, Pennsylvania, United States
• Texas Oncology-Baylor Charles A. Sammons Cancer Center — Dallas, Texas, United States
• Texas Oncology-Denton South — Denton, Texas, United States
• Texas Oncology, P.A. - Flower Mound — Flower Mound, Texas, United States
• Texas Oncology-Fort Worth Cancer Center — Fort Worth, Texas, United States
• Texas Oncology-Memorial City — Houston, Texas, United States
• Texas Oncology-Midland Allison Cancer Center — Midland, Texas, United States
• University of Texas at San Antonio — San Antonio, Texas, United States
• Texas Oncology-Sherman — Sherman, Texas, United States
• Texas Oncology-Tyler — Tyler, Texas, United States
• Texas Oncology -Waco — Waco, Texas, United States
• Virginia Oncology Associates — Norfolk, Virginia, United States
• CIPREC — Buenos Aires, Argentina
• Investigaciones Clinico Moleculares (ICM) — CABA, Argentina
• Arizona Oncology Associates, PC - HOPE — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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