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Chronic Intestinal Pathologies Analytical Cohort at TouLouse (CAPITOL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04896684
Recruitment Status : Recruiting
First Posted : May 21, 2021
Last Update Posted : November 16, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
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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.

Condition or disease Intervention/treatment
Inflammatory Bowel Diseases Colon Cancer 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 Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chronic Intestinal Pathologies Analytical Cohort at TouLouse
Actual Study Start Date : April 29, 2021
Estimated Primary Completion Date : January 3, 2023
Estimated Study Completion Date : April 12, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Biological collection associated with clinical data [ Time Frame: Baseline ]
    Set up a biological collection associated with clinical data on main intestinal tract diseases in order to understand their physiopathology

  2. Biological collection associated with clinical data [ Time Frame: 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 :
  1. Identify new potential therapeutic molecules [ Time Frame: Baseline ]
    Assessment of new treatment on organoids made thanks to intestinal biopsies

  2. Optimize treatment success rates for IBD [ Time Frame: Baseline ]
    Assessment of new treatment on organoids made thanks to intestinal biopsies


Biospecimen Retention:   Samples With DNA
colon biopsies, blood samples

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04896684


Contacts
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Contact: Barbara Bournet, MD, PhD 5 61 32 32 35 ext 0033 bournet.b@chu-toulouse.fr
Contact: Cindy Canivet 5 61 32 20 48 ext 0033 canivet.c@chu-toulouse.fr

Locations
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France
Rangueil University Hospital Recruiting
Toulouse, France, 31059
Contact: Barbara Bournet, MD, PhD    5 61 32 32 35 ext 0033    bournet.b@chu-toulouse.fr   
Contact: Cindy Canivet    5 61 32 20 48 ext 0033    canivet.c@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Toulouse
More Information
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT04896684    
Other Study ID Numbers: RC31/21/0038
First Posted: May 21, 2021    Key Record Dates
Last Update Posted: November 16, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Intestinal Bowel syndrome
Inflammatory Bowel Disease
colon cancer screening
data and biological collection
Additional relevant MeSH terms:
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Colonic Neoplasms
Intestinal Diseases
Inflammatory Bowel Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Gastroenteritis