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

  • End date
    Jun 9, 2023
  • participants needed
  • sponsor
    Janssen Research & Development, LLC
Updated on 28 June 2022
growth factor
transitional cell carcinoma


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.

Condition Urothelial Cancer, Receptors, Fibroblast Growth Factor
Treatment Archival Tumor Tissue Sample
Clinical Study IdentifierNCT03955913
SponsorJanssen Research & Development, LLC
Last Modified on28 June 2022


Yes No Not Sure

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

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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