Chronic Intestinal Pathologies Analytical Cohort at TouLouse (CAPITOL)
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| ClinicalTrials.gov Identifier: NCT04896684 |
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Recruitment Status :
Recruiting
First Posted : May 21, 2021
Last Update Posted : November 16, 2022
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Sponsor:
University Hospital, Toulouse
Information provided by (Responsible Party):
University Hospital, Toulouse
| Tracking Information | |||||||||
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| 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 |
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
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| 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. |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: colon biopsies, blood samples
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | primary care clinic | ||||||||
| Condition |
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| Intervention | Biological: blood and intestinal biopsy sampling
24 mL of blood and 10 intestinal biopsies will be sampled
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| 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
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
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:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 99 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| 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 |
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| IPD Sharing Statement |
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| 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 | ||||||||