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

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04567446
• Collaborator: (none)
• Enrollment: 1,100
• Location: 1
• Anticipated Duration (Months): 59.3
• Patients Per Site Per Month: 18.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cancer	Other: Stool; Other: Blood sample; Other: Saliva

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Discovery of Microbiome-based Biomarkers for Patients With Cancer Using Metagenomic
• Actual Study Start Date: Jan 22, 2018
• Anticipated Primary Completion Date: Jan 1, 2021
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

Arm

Intervention/Treatment

Patients who will start cancer treatment Collection of biological samples (stool, blood, saliva) and data from patients included in the study will be performed: By identifying the patients who will start treatment anticancer (chemotherapy, hormone therapy, immunotherapy). Collection of biological resources (all samples will be collected in fresh): Stool: collected at diagnosis, before initiating anticancer treatment, during treatment Blood: 40 mL collection before, 3 and 6 months of treatment cancer Saliva: 5 mL collection before initiation of treatment cancer Collection of clinical data corresponding to each patient included in the study by a clinical research assistant

Other: Stool; collection at diagnosis, before initiating anticancer treatment, during treatment; Other: Blood sample; 40 mL collection before, 3 and 6 months of treatment cancer; Other: Saliva; 5 mL collection before initiation of treatment cancer

Outcome Measures

Primary Outcome Measures

1. To define metagenomic signatures associated with cancer [Up to 2 years]

   overall survival

2. To Define metagenomic signatures associated with the effectiveness of anticancer therapies [Up to 2 years]

   objective response rate, progression free survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gustave Roussy	Villejuif	Val De Marne	France	94800

Sponsors and Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
• ClinicalTrials.gov Identifier: NCT04567446
• Other Study ID Numbers: 2017-A02010-53; 2019/2619
• First Posted: Sep 28, 2020
• Last Update Posted: Sep 28, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 28, 2020