Characteristics of the Intestinal Microbiota in Patients With Cancer (Catalogue-Onco)

Characteristics of the Intestinal Microbiota in Patients With Cancer (Catalogue-Onco)

In order to understand how the intestinal microbiota plays a role in the effectiveness of an anti-cancer treatment by an immune control point inhibitor, this study aims to constitute a catalog of microbial genes of a patient with cancer. This catalog will help to characterize the intestinal microbiota of cancer patients and to be able to use this catalog as a reference tool for screening the microbiota of patients treated with immune control point inhibitors. To produce this catalog, five types of cancer were selected: non-small cell lung cancer, colorectal cancer, hepatocellular carcinoma, breast cancer and prostate cancer.

The metagenomic analysis of a group of five different types of cancers introduces a lot of heterogeneity which is favorable to the richness of a catalog. For non-small cell lung cancer treated with immune control point inhibitors, two stool collections will be performed per patient (one stool collection before setting up an immune control point inhibitor and one collection after one month of being inhibited Of immune control point) to assess the impact of the immune control point inhibitor on the microbiota (pilot study). For this study, two stool collection tubes containing different preservative solutions will be used (one RNAlater tube and one DMSO-EDTA tube for Dimethylsulfoxide-Ethylene diamine tetraacetic acid).

In parallel, we will also collect samples of serum and plasma to evaluate, in a second step, protein markers in circulating blood.

Study Overview

• Status: Completed
• Conditions: Oncology
• Intervention / Treatment: Biological: Collection of stool and serum samples

Detailed Description

Primary objective: Develop a catalog of microbial genes dedicated to oncology (Onco catalog) by sequencing stool specimens from patients with cancer.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21079
    • Centre Georges-François Leclerc
  • Villejuif, France, 94800
    • Hôpital Universitaire Paul Brousse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men or women between 18 and 75 years of age.
• Patients with one of the following types of cancer: non-small cell lung cancer, hepatocellular carcinoma, colorectal cancer, breast cancer, prostate cancer and glioblastoma
• Patients with informed consent to participate in the study.
• Affiliation to the social security system

Exclusion Criteria:

• For patients with hepatocellular cancer, patients infected with the human immunodeficiency virus (HIV)
• Patients who are unable to understand, read and / or sign informed consent
• Patients who can not collect / send stools for geographical, social or psychological reasons
• Patients with previous cancer in the 5 years preceding this study
• Persons benefiting from a system of protection for adults (including guardianship and curatorship)
• Pregnant or nursing women
• Patients with another synchronous tumor
• Patients with fecal transplant
• Patients with chronic inflammatory bowel disease (IBD)
• Patients having had in the 3 months preceding the collection of stool: colonoscopy, bariatric surgery, surgical removal of a segment of the small intestine (enteritomy or enterostomy), parenteral nutrition.
• Patients who had had antibiotic therapy within 1 month before stool collection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohorte; This cohort will consist of patients as described below: 15 patients with non-small cell lung cancer (NSCLC); 10 patients with hepatocellular cancer:; 10 patients with colorectal cancer; 10 patients with breast cancer; 10 patients with prostate cancer; 10 patients with glioblastoma	Biological: Collection of stool and serum samples; During the inclusion visit (for the 5 cancer sites): Stool collection (1 tube RNA later + 1 tube DMQO-EDTA) +Blood sample (1 tube SST + 1 tube EDTA) 1 month after treatment (only for non-small cell lung cancer): Stool collection (1 tube RNA later + 1 tube DMQO-EDTA) + Blood sample (1 tube SST + 1 tube EDTA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbial DNA	Bio-computer and bio-statistical analyzes will be carried out in order to constitute the gene catalog.	inclusion

Collaborators and Investigators

• Sponsor: Centre Georges Francois Leclerc
• Collaborators: Enterome

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2017
• Primary Completion (Actual): February 6, 2017
• Study Completion (Actual): July 5, 2018

Study Registration Dates

• First Submitted: June 21, 2017
• First Submitted That Met QC Criteria: June 22, 2017
• First Posted (Actual): June 23, 2017

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 23, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Intestinal microbiota, microbial genes, oncology
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: Catalogue-Onco

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No