cropped color_logo_with_background.png

Characteristics of the Intestinal Microbiota in Patients With Cancer

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03196609
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Centre Georges Francois Leclerc
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Completed
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Oncology
Additional Details

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

Arms & Interventions

Arms

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

Interventions

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)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Centre Georges-François Leclerc, Dijon, France

Status

Address

Centre Georges-François Leclerc

Dijon, , 21079

Hopital Universitaire Paul Brousse, Villejuif, France

Status

Address

Hopital Universitaire Paul Brousse

Villejuif, , 94800