Characteristics of the Intestinal Microbiota in Patients... | NCT03196609

Studies
Characteristics of the Intestinal Microbiota in Patients With Cancer

NCT03196609

Sponsor

Centre Georges Francois Leclerc

Status

Completed

Last Update Posted

Jan 27, 2020Actual

Enrollment

69Actual

Phase

Not Applicable

Conditions

Oncology

Interventions

Collection of stool and serum samples

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 6, 2017Actual

Primary Completion Date

Feb 6, 2017Actual

Completion Date

Jul 5, 2018Actual

First Submitted Date

Jun 21, 2017

First Submission Date that Met QC Criteria

Jun 22, 2017

First Posted Date

Jun 23, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2020

Last Update Posted Date

Jan 27, 2020Actual

Name	Class
Enterome	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

69Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohorte	Experimental	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	Biological: Collection of stool and serum samples

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Centre Georges-François Leclerc		Dijon		21079	France
Hopital Universitaire Paul Brousse