Clinical trial · Observational
A Study to Identify Participants With Urothelial Cancer and Fibroblast Growth Factor Receptor Gene Aberrations
Biomarker Study to Identify Subjects With Urothelial Cancer and Fibroblast Growth Factor Receptor Gene Aberrations
NCT03955913CI-TRIAL-00064218completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Receptors, Fibroblast Growth Factor | — | UNRESOLVED | — |
| Urothelial Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Archival Tumor Tissue Sample | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Participants with Urothelial Cancer,selected FGFR aberrations
- description
- Participants with urothelial cancer (UC) will be evaluated for the prevalence of positive results of selected fibroblast growth factor receptor (FGFR) aberrations and will be assessed for eligibility status for erdafitinib studies. The primary data source for this study will be the medical records of each participant.
- interventionNames
- Other: Archival Tumor Tissue Sample
Primary outcomes (1)
- measure
- Percentage of Participants with Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations
- timeFrame
- Up to 3.9 years
- description
- Percentage of participants with selected FGFR gene aberrations will be assessed through molecular testing of their archival tumor tissue.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: \-
References
Publications (0)
Data not yet available
No reference posted for this study.