Discovery of Microbiome-based Biomarkers for Patients With Cancer Using Metagenomic Approach
ONCOBIOTICS
2 other identifiers
observational
1,100
1 country
9
Brief Summary
Multicentric prospective study with collection of biological samples as part of type II research
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2018
Longer than P75 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 22, 2018
CompletedFirst Submitted
Initial submission to the registry
February 10, 2020
CompletedFirst Posted
Study publicly available on registry
September 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedJune 12, 2024
June 1, 2024
6.9 years
February 10, 2020
June 11, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival
To define metagenomic signatures associated with cancer
Up to 2 years
Study Arms (3)
Patients with bladder cancer who will start cancer treatment
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
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
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
Interventions
collection at baseline (or before the third injection), at the first evaluation (CT-scan), at ≥ 6 months after the first injection, at toxicity and at relapse, at 1 week after the end of antibiotics treatment
20 mL collection at baseline (or before the third injection), at the first evaluation (CT-scan), at ≥ 6 months after the first injection, at toxicity and at relapse, at 1 week after the end of antibiotics treatment
Eligibility Criteria
Patient with cancer who will start treatment anticancer
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Gustave Roussy
Villejuif, Val De Marne, 94800, France
Centre hospitalier du Pays d'Aix
Aix-en-Provence, 13616, France
Centre Pierre Curie
Beuvry, 62660, France
Clinique du Flandre
Coudekerque-Branche, 59210, France
CHRU Lille - Hôpital Calmette
Lille, 59037, France
Centre Léon Bérard
Lyon, 69008, France
Hôpital St Louis
Paris, 75010, France
Hôpital Foch
Suresnes, 92151, France
Centre hospitalier TOULON - Sainte-Musse
Toulon, 83056, France
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2020
First Posted
September 28, 2020
Study Start
January 22, 2018
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
June 12, 2024
Record last verified: 2024-06