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Chronic Intestinal Pathologies Analytical Cohort at TouLouse (CAPITOL)

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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

Tracking Information
First Submitted Date May 3, 2021
First Posted Date May 21, 2021
Last Update Posted Date November 16, 2022
Actual Study Start Date April 29, 2021
Estimated Primary Completion Date January 3, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 20, 2021)
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 20, 2021)
  • Identify new potential therapeutic molecules [ Time Frame: Baseline ]
    Assessment of new treatment on organoids made thanks to intestinal biopsies
  • Optimize treatment success rates for IBD [ Time Frame: Baseline ]
    Assessment of new treatment on organoids made thanks to intestinal biopsies
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Chronic Intestinal Pathologies Analytical Cohort at TouLouse
Official Title Chronic Intestinal Pathologies Analytical Cohort at 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
colon biopsies, blood samples
Sampling Method Non-Probability Sample
Study Population primary care clinic
Condition
  • Inflammatory Bowel Diseases
  • Colon Cancer
Intervention Biological: blood and intestinal biopsy sampling
24 mL of blood and 10 intestinal biopsies will be sampled
Study Groups/Cohorts Patient screened or followed-up for IBS or IBD or colorectal cancer
Blood and colon biopsy sampling
Intervention: Biological: blood and intestinal biopsy sampling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 20, 2021)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 12, 2023
Estimated Primary Completion Date January 3, 2023   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04896684
Other Study ID Numbers RC31/21/0038
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party University Hospital, Toulouse
Original Responsible Party Same as current
Current Study Sponsor University Hospital, Toulouse
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account University Hospital, Toulouse
Verification Date November 2022