NCT03196609

Characteristics of the Intestinal Microbiota in Patients With Cancer

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Centre Georges Francois Leclerc · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Oncology

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2017-02-06
• Primary completion: 2017-02-06
• Completion: 2018-07-05
• First posted: 2017-06-23
• Last updated: 2020-01-27

Locations

2 sites across 1 country: France