Clinical trial NCT04896684: Chronic Intestinal Pathologies Analytical Cohort at TouLouse
Official title: Chronic Intestinal Pathologies Analytical Cohort at TouLouse
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammatory Bowel Diseases
Colon Cancer
Keywords: Intestinal Bowel syndrome
Inflammatory Bowel Disease
colon cancer screening
data and biological collection
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

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.

Eligibility criteria: 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

Primary outcomes:
measure: Biological collection associated with clinical data
timeFrame: Baseline
measure: Biological collection associated with clinical data
timeFrame: pre-intervention/procedure/surgery
Secondary outcomes:
measure: Identify new potential therapeutic molecules
timeFrame: Baseline
measure: Optimize treatment success rates for IBD
timeFrame: Baseline
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Rangueil University Hospital
Study officials:
affiliation: University Hospital, Toulouse
name: Barbara Bournet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: