Digestive Biobank for Exploring Microbiota-host Interactions

NCT ID: NCT05704413

Last Updated: 2023-01-30

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-17

Study Completion Date

2026-09-17

Brief Summary

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Constitution of a biobank of tissues, whole blood and plasma samples and stools to identify markers associated with treatment response, postoperative morbidity including neuro-cognitive and mood complications and prognosis of Inflammatory Bowel disease or colorectal cancer.

Detailed Description

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Inflammatory Bowel disease (Crohn, Ulcerative colitis) and colorectal cancer are frequent affections and the microbiota plays a major role in their physiopathology involving the immune system. In this setting, the interplay between gut microbiota and brain is still unexplored.

To evaluate the interaction of the microbiota and the immune system with the host in these two chronic diseases, we aim to create a prospective biobank.

A small amount of tissue will be taken during surgery. A whole blood, plasma and stoll samples will also be taken from the patient.

All samples will be anonymized.

Conditions

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Inflammatory Bowel Diseases Crohn Disease Ulcerative Colitis Colorectal Cancer Indeterminate Colitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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digestive cancer or IBD

Patient with digestive cancer or IBD having surgery with intestinal resection planned in the Visceral Surgery Department of St Antoine Hospital

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Ulcerative colitis, Crohn's disease or colorectal disease
* Digestive resection with useless tissue available
* Information consent signed

Exclusion Criteria

\- Patients \< 18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jérémie LEFEVRE, PU-PH

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Service de Chirurgie Viscérale - Hôpital Saint Antoine

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jérémie LEFEVRE, PU-PH

Role: CONTACT

+33 (0)1 49 28 25 63

Harry SOKOL, PU-PH

Role: CONTACT

+33 (0)1 49 28 31 71

Facility Contacts

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Jérémie LEFEVRE, PU-PH

Role: primary

+33 (0)1 49 28 25 63

Harry SOKOL, PU-PH

Role: backup

+33 (0)1 49 28 25 63

Other Identifiers

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APHP180540

Identifier Type: -

Identifier Source: org_study_id

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