Chronic Intestinal Pathologies Analytical Cohort at TouLouse

Colon Cancer Clinical Trial

— CAPITOL  

Official title:

Chronic Intestinal Pathologies Analytical Cohort at TouLouse

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04896684
• Other study ID #: RC31/21/0038
• Status: Recruiting
• Start date: April 29, 2021
• Est. completion date: September 2025

Study information

• Verified date: June 2023
• Source: University Hospital, Toulouse
• Contact: Barbara Bournet, MD, PhD
• Phone: 5 61 32 32 35
• Email: bournet.b[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Biological:
• blood and intestinal biopsy sampling
24 mL of blood and 10 intestinal biopsies will be sampled

Locations

Country	Name	City	State
France	Rangueil University Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Identify new potential therapeutic molecules	Assessment of new treatment on organoids made thanks to intestinal biopsies	Baseline
Secondary	Optimize treatment success rates for IBD	Assessment of new treatment on organoids made thanks to intestinal biopsies	Baseline