Clinical trial NCT03196609: Characteristics of the Intestinal Microbiota in Patients With Cancer
Official title: Characteristics of the Intestinal Microbiota in Patients With Cancer (Catalogue-Onco)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oncology
Keywords: Intestinal microbiota, microbial genes, oncology
Lead sponsor: Centre Georges Francois Leclerc
Sponsor class: OTHER
Collaborators: name: Enterome
First posted: 2017-06-23
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This cohort will consist of 55 patients as described below:

* non-small cell lung cancer (NSCLC)
* hepatocellular cancer:
* colorectal cancer
* breast cancer
* prostate cancer
* glioblastoma
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Microbial DNA
timeFrame: inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre Georges-François Leclerc
city: Villejuif
country: France
facility: Hopital Universitaire Paul Brousse
Study officials:
References: