Discovery of Microbiome-based Biomarkers for Patients With Cancer Using Metagenomic Approach

Recruiting

• Conditions: Cancer
• Interventions: Other: Stool; Other: Blood sample

• Registration Number: NCT04567446
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary

Multicentric prospective study with collection of biological samples as part of type II research

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-22
• Study First Submitted: 2020-02-10
• Study First Submitted QC: 2020-09-23
• Study First Posted: 2020-09-28
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-12
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

• Patient with cancer who will start treatment anticancer (see cohorts).
• Patient information and signature of the consent form before any specific procedure for the study. The patient must be able and must be inclined to cooperate in the study procedures.
• Patient affiliated to a social security scheme or beneficiary of a similar scheme.

Exclusion Criteria

• Pregnant or lactating woman
• Patient under guardianship or curatorship or deprived of liberty by a decision judicial or administrative or patient unable to give his consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with bladder cancer who will start cancer treatment	Stool	Collection of biological samples (stool and blood) and data from patients included in the study will be performed: 1. By identifying the patients who will start treatment anticancer (chemotherapy, hormone therapy, immunotherapy). 2. Collection of biological resources (all samples will be collected in fresh): stool and blood 3. Collection of clinical data corresponding to each patient included in the study by a clinical research assistant
Patients with kidney cancer who will start cancer treatment	Stool	Collection of biological samples (stool and blood) and data from patients included in the study will be performed: 1. By identifying the patients who will start treatment anticancer (chemotherapy, hormone therapy, immunotherapy). 2. Collection of biological resources (all samples will be collected in fresh): stool and blood 3. Collection of clinical data corresponding to each patient included in the study by a clinical research assistant
Patients with kidney cancer who will start cancer treatment	Blood sample	Collection of biological samples (stool and blood) and data from patients included in the study will be performed: 1. By identifying the patients who will start treatment anticancer (chemotherapy, hormone therapy, immunotherapy). 2. Collection of biological resources (all samples will be collected in fresh): stool and blood 3. Collection of clinical data corresponding to each patient included in the study by a clinical research assistant
Patients with bladder cancer who will start cancer treatment	Blood sample	Collection of biological samples (stool and blood) and data from patients included in the study will be performed: 1. By identifying the patients who will start treatment anticancer (chemotherapy, hormone therapy, immunotherapy). 2. Collection of biological resources (all samples will be collected in fresh): stool and blood 3. Collection of clinical data corresponding to each patient included in the study by a clinical research assistant
Patients with Non-Small-Cell Lung cancer who will start cancer treatment	Stool	Collection of biological samples (stool and blood) and data from patients included in the study will be performed: 1. By identifying the patients who will start treatment anticancer (chemotherapy, hormone therapy, immunotherapy). 2. Collection of biological resources (all samples will be collected in fresh): stool and blood 3. Collection of clinical data corresponding to each patient included in the study by a clinical research assistant
Patients with Non-Small-Cell Lung cancer who will start cancer treatment	Blood sample	Collection of biological samples (stool and blood) and data from patients included in the study will be performed: 1. By identifying the patients who will start treatment anticancer (chemotherapy, hormone therapy, immunotherapy). 2. Collection of biological resources (all samples will be collected in fresh): stool and blood 3. Collection of clinical data corresponding to each patient included in the study by a clinical research assistant

Primary Outcome Measures

Name	Time	Method
Overall survival	Up to 2 years	To define metagenomic signatures associated with cancer

Trial Locations

Locations (9)

Hôpital Foch; 🇫🇷 Suresnes, France

Gustave Roussy; 🇫🇷 Villejuif, Val De Marne, France

Clinique du Flandre; 🇫🇷 Coudekerque-Branche, France

Centre Pierre Curie; 🇫🇷 Beuvry, France

Centre hospitalier du Pays d'Aix; 🇫🇷 Aix-en-Provence, France

CHRU Lille - Hôpital Calmette; 🇫🇷 Lille, France

Centre Léon Bérard; 🇫🇷 Lyon, France

Hôpital St Louis; 🇫🇷 Paris, France

Centre hospitalier TOULON - Sainte-Musse; 🇫🇷 Toulon, France