Characteristics of the Intestinal Microbiota in Patients With Cancer

Oncology Clinical Trial

— Catalogue-Onco  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03196609
• Other study ID #: Catalogue-Onco
• Status: Completed
• Phase: N/A
• Start date: February 6, 2017
• Est. completion date: July 5, 2018

Study information

• Verified date: January 2020
• Source: Centre Georges Francois Leclerc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: July 5, 2018
• Est. primary completion date: February 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Oncology

Intervention

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)

Locations

Country	Name	City	State
France	Centre Georges-François Leclerc	Dijon
France	Hopital Universitaire Paul Brousse	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
Centre Georges Francois Leclerc	Enterome

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbial DNA	Bio-computer and bio-statistical analyzes will be carried out in order to constitute the gene catalog.	inclusion