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临床试验/NCT03955913
NCT03955913已完成不适用

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

Janssen Research & Development, LLC199 个研究点 分布在 4 个国家目标入组 3,679 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,679
试验地点
199
主要终点
Percentage of Participants with Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

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

时间窗: Up to 3.9 years

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

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (199)

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