Characteristics of the Intestinal Microbiota in Patients With Cancer

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.

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Key information

Conditions

Oncology Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Georges-François Leclerc, Dijon, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collection of stool and serum samples

Biological

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)

Primary outcomes

Microbial DNA

Time frame: inclusion

Bio-computer and bio-statistical analyzes will be carried out in order to constitute the gene catalog.

Sponsors and collaborators

Lead sponsor

Centre Georges Francois Leclerc

Other

Collaborators

Enterome

Registry information

Official study title

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

Acronym: Catalogue-Onco

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2018
First posted: Jun 23, 2017
Registry last updated: Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed