Chronic Intestinal Pathologies Analytical Cohort at TouLouse (CAPITOL)

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases; Colon Cancer
• Intervention / Treatment: Biological: blood and intestinal biopsy sampling

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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Barbara Bournet, MD, PhD; Phone Number: 0033 5 61 32 32 35; Email: bournet.b@chu-toulouse.fr
• Study Contact Backup: Name: Cindy Canivet; Phone Number: 0033 5 61 32 20 48; Email: canivet.c@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France, 31059
    • Recruiting
    • Rangueil University Hospital
    • Contact: Barbara Bournet, MD, PhD; Phone Number: 0033 5 61 32 32 35; Email: bournet.b@chu-toulouse.fr
    • Contact: Cindy Canivet; Phone Number: 0033 5 61 32 20 48; Email: canivet.c@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient screened or followed-up for IBS or IBD or colorectal cancer; Blood and colon biopsy sampling	Biological: blood and intestinal biopsy sampling; 24 mL of blood and 10 intestinal biopsies will be sampled

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify new potential therapeutic molecules	Assessment of new treatment on organoids made thanks to intestinal biopsies	Baseline
Optimize treatment success rates for IBD	Assessment of new treatment on organoids made thanks to intestinal biopsies	Baseline

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Barbara BOURNET, MD, PhD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2021
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: May 3, 2021
• First Submitted That Met QC Criteria: May 20, 2021
• First Posted (Actual): May 21, 2021

Study Record Updates

• Last Update Posted (Actual): June 28, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Inflammatory Bowel Disease; colon cancer screening; Intestinal Bowel syndrome; data and biological collection
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Inflammatory Bowel Diseases; Intestinal Diseases; Colonic Neoplasms
• Other Study ID Numbers: RC31/21/0038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No