Characteristics of the Intestinal Microbiota in Patients With Cancer
NCT ID: NCT03196609
Last Updated: 2020-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
69 participants
INTERVENTIONAL
2017-02-06
2018-07-05
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
* non-small cell lung cancer (NSCLC)
* hepatocellular cancer:
* colorectal cancer
* breast cancer
* prostate cancer
* glioblastoma
DIAGNOSTIC
NONE
Study Groups
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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
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Enterome
INDUSTRY
Centre Georges Francois Leclerc
OTHER
Responsible Party
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Locations
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Centre Georges-François Leclerc
Dijon, , France
Hopital Universitaire Paul Brousse
Villejuif, , France
Countries
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Other Identifiers
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Catalogue-Onco
Identifier Type: -
Identifier Source: org_study_id
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