Receptors, Fibroblast Growth Factor, Urothelial Cancer
Conditions
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.
Interventions
OTHERArchival Tumor Tissue Sample
Percentage of participants with UC and selected FGFR aberrations will be assessed through molecular testing of their archival tumor tissue.
Sponsors
Janssen Research & Development, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Argentina, Belgium, Brazil, France, Germany, Israel, Italy, Japan, Russia, Spain, Turkey (Türkiye), Ukraine, United Kingdom, United States
Outcome results
None listed