跳至主要内容
临床试验/NCT05204199
NCT05204199招募中不适用

Towards Individualization of Bladder Cancer Therapy: the Role of Microbiome in BCG Responsiveness Prediction

Cédric Poyet5 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年2月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
5
主要终点
Difference in microbial Profile

研究概览

简要总结

Our primary aim is to investigate the use of microbial profile from the bladder and the feces of NMIBC patients as a predicting tool for therapy response prior to BCG administration.

Our second aim is to collect additional samples (blood, instrumented urine, bladder tissue, feces) to establish a local biobank for future microbiome projects.

详细描述

The microbiome, defined as a characteristic microbial community occupying a reasonably well-defined environment (e.g. gut microbiome), has been increasingly linked with different medical conditions and also with cancer. While there have been numerous investigations into the gut bacterial ecosystem, scientists have started to pay attention to the microbiome of the bladder only recently. Results from newest investigations support the understanding that the bladder possesses its own microbiome and it is not germ-free. Studying the relationship between bladder cancer and bladder and gut microbiome may lead to new insights which can be used to predict tumor behavior and/or response to therapy.

With this project, we aim to investigate the use of microbial fingerprint from the bladder and from the feces of bladder cancer patients in predicting therapy response prior to administration of Bacillus Calmette-Guerin or BCG. BCG causes the body's own immune system to attack the bladder cancer cells. It is applied directly into the bladder to prevent the cancer from growing and from regrowing. However, in around 40% of patients this treatment is not successful, BCG should be avoided, and other therapy strategies should be chosen. Unfortunately, there is no test available yet, which help to select patients who will benefit from the therapy before the therapy is started.

In this project we intend to determine the microbial fingerprint and to analyze if this fingerprint can be used as a selection tool. This tool may enable as us in the future to avoid application of BCG therapy for patient with a high risk of therapy failure and save time to start alternative therapy options and hopefully avoid tumor progression. Our second aim is to collect additional samples (blood, instrumented urine, bladder tissue, feces) to establish a local biobank for future microbiome projects.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Difference in microbial Profile

时间窗: 1 year

use of microbial profile from the bladder and the feces of NMIBC patients as a potential binary classification system, to substratify BCG-candidates into "anticipated BCG-responder (aBCGr)" and "anticipated BCG-non-responder (aBCGnr)" groups in predicting therapy response prior to BCG administration.

次要结局

  • Biobank(1 year)

研究者

发起方
Cédric Poyet
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Cédric Poyet

Principal Investigator

University of Zurich

研究点 (5)

Loading locations...

相似试验