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

CompletadoClinicalTrials.gov

ID: NCT03955913Tipo: OBSERVATIONALInicio: 1 de ago de 2019Fin estimado: 19 de sept de 2022

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

Intervenciones

other

Archival Tumor Tissue Sample

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

Ubicaciones

CIPREC

Buenos Aires, Argentina

Investigaciones Clinico Moleculares (ICM)

CABA, Argentina

FUCDIM - Centro Urológico Modelo

Córdoba, Argentina

Sanatorio Allende Cerro

Córdoba, Argentina

Instituto Médico de Río Cuarto

Córdoba, Argentina

Hospital Privado de Cordoba

Córdoba, Argentina

Sanatorio Mayo SA

Santa Fe, Argentina

Patrocinadores

PrincipalJanssen Research & Development, LLC

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