跳至主要内容
临床试验/NCT06116396
NCT06116396招募中不适用

Use of Urinary Tumor Cells and Circulating Tumor Cells (CTCs) in the Prognosis and Therapy of Patients With Bladder (BCa) and Upper Urinary Tract (UTUC) Cancer"

IRCCS San Raffaele1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2020年9月29日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
450
试验地点
1
主要终点
Prognostic role of the liquid biopsy

研究概览

简要总结

The project aims to characterize the prognostic role of CTCs in Bladder cancer patients, with the specific aims to better stratify patients with non-muscle invasive bladder cancer at the first transurethral resection of tumor and to identify urothelial biomarker expressed by CTCs.

详细描述

Bladder cancer (BCa) is the 9th most common cancer worldwide, with an estimated prevalence of around 2.7 million cases and an incidence around 350.000 new cases/year. The proper management of BCa remains an unmet clinical need, because one of the main problems in BCa treatment is the inability to efficaciously prevent high-grade non-muscle invasive bladder cancer (NMIBC) relapse and progression, which occur in 80% and 45% of patients respectively. Indeed, as a consequence of the lack of efficient established prognostic, diagnostic and predictive biomarker of high-risk NMIBC, Bca patients undergo multiple treatments and cystoscopic assessments along their life, with consequent poor quality of life and high healthcare costs.

Circulating Tumor Cells (CTCs) in blood represent an invaluable source of tumor material that can be easily collected yhrough a simple blood draw and may represent the clonal component of the primary tumor that left the primary site.

For this reason, the aim of this study is to characterize the prognostic role of CTCs in Bladder cancer patients, with the specific aims to better stratify patients with non-muscle invasive bladder cancer at the first transurethral resection of tumor and to identify urothelial biomarker expressed by CTCs.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

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

入选标准

  • Diagnosis of urothelial neoplasia, naive for therapy

排除标准

  • Absence of previous neolpastic disease or genetic diseases

结局指标

主要结局

Prognostic role of the liquid biopsy

时间窗: 2020-2023

Gene signature in CTC and UTC predicting tumor relapse

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Massimo Alfano

PhD

IRCCS San Raffaele

研究点 (1)

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