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

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.

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Key information

Conditions

Urothelial Cancer Acrocephalosyndactylia Bone Diseases Bone Diseases, Developmental Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Craniosynostoses Dysostoses Limb Deformities, Congenital Musculoskeletal Abnormalities Musculoskeletal Diseases Receptors, Fibroblast Growth Factor Syndactyly Synostosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CIPREC, Buenos Aires, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Archival Tumor Tissue Sample

Other

Percentage of participants with UC and selected FGFR aberrations will be assessed through molecular testing of their archival tumor tissue.

Primary outcomes

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

Time frame: Up to 3.9 years

Percentage of participants with selected FGFR gene aberrations will be assessed through molecular testing of their archival tumor tissue.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2022
Study completion: 2022
First posted: May 20, 2019
Registry last updated: Feb 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed