Role of Microbiome in BCG Responsiveness Prediction

Recruiting

• Conditions: Bladder Cancer; Microbiome

• Registration Number: NCT05204199
• Lead Sponsor: Cédric Poyet

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-12-29
• Study First Submitted QC: 2022-01-10
• Study First Posted: 2022-01-24
• Study Start: 2022-02-22
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-05
• Primary Completion: 2025-10-20
• Study Completion: 2025-10-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in microbial Profile	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.

Secondary Outcome Measures

Name	Time	Method
Biobank	1 year	collect additional samples (blood, instrumented urine, bladder tissue, feces) to establish a local biobank for future microbiome projects

Trial Locations

Locations (5)

University Hospital Zürich; 🇨🇭 Zürich, Switzerland

Spitalzentrum Biel; 🇨🇭 Biel, Bern, Switzerland

Kantonsspital St. Gallen; 🇨🇭 St. Gallen, Saint Gallen, Switzerland

Kantonsspital Baden; 🇨🇭 Baden, Aargau, Switzerland

Kantonsspital Winterthur; 🇨🇭 Winterthur, Zürich, Switzerland