Chronic Intestinal Pathologies Analytical Cohort at TouLouse

Recruiting

• Conditions: Inflammatory Bowel Diseases; Colon Cancer
• Interventions: Biological: blood and intestinal biopsy sampling

• Registration Number: NCT04896684
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

In the general population, the percentage of people with at least one digestive disease is 16.7%. Among these digestive diseases, inflammatory bowel disease (IBD), irritable bowel syndrome (IBS) and patients who should benefit from digestive examinations as part of a screening oriented either by the patient's family history or following the performance of an immunological screening test ( FIT) in the stool will be studied. The aim of this project is to build a biological collection with associated clinical data for research projects.

Detailed Description

In the general population, the percentage of people with at least one digestive disease is 16.7%. Among these digestive diseases, two of them namely inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS) will be more particularly studied. This interest is based on the increasing frequency of these two pathologies, their chronicities but above all the limited physiopathological data available. In addition, it seems interesting to study a third population, namely patients who should benefit from digestive examinations as part of a screening oriented either by the patient's family history or following the performance of an immunological screening test ( FIT) in the stool. The study of this population is part of an improvement in knowledge on the carcinogenesis of colorectal cancer.

To study these populations, blood, serum, plasma and tissues from colonous biopsies or surgical samples will be collected.

This cohort will make it possible to study, among other things, the pathophysiology of chronic diseases of the small intestine and the colon (IBD, IBS, screening) in order to improve their management through the development of new biomarkers and therapeutic targets.

Study Timeline

• Study Start: 2021-04-29
• Study First Submitted: 2021-05-03
• Study First Submitted QC: 2021-05-20
• Study First Posted: 2021-05-21
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-06-28
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patient requiring endoscopic explorations for screening or follow-up in the context of a suspected IBS or IBD or colorectal cancer Or
• Patient with IBD requiring surgical management
• Patient over 18 years old
• Patient able to read and understand the information leaflet
• Patients who have given their consent to participate in the study
• Patients affiliated to a social security system (including AME)

Exclusion Criteria

• Patients who have received antibiotic treatments in the 10 days preceding endoscopic exploration
• Pregnant or breastfeeding patients
• Patients under 18 years old
• Patients under guardianship or curatorship
• Patients unable to sign a free and informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient screened or followed-up for IBS or IBD or colorectal cancer	blood and intestinal biopsy sampling	Blood and colon biopsy sampling

Primary Outcome Measures

Name	Time	Method
Biological collection associated with clinical data	pre-intervention/procedure/surgery	Set up a biological collection associated with clinical data on main intestinal tract diseases in order to understand their physiopathology

Secondary Outcome Measures

Name	Time	Method
Identify new potential therapeutic molecules	Baseline	Assessment of new treatment on organoids made thanks to intestinal biopsies
Optimize treatment success rates for IBD	Baseline	Assessment of new treatment on organoids made thanks to intestinal biopsies

Trial Locations

Locations (1)

Rangueil University Hospital; 🇫🇷 Toulouse, France