Inflammatory Bowel DiseasesCAPITOLNCT04896684
Chronic Intestinal Pathologies Analytical Cohort at TouLouse
An observational study of Inflammatory Bowel Diseases and Colon Cancer, run by University Hospital, Toulouse at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Colon Cancer
- What is being tested?
- blood and intestinal biopsy sampling
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 29 Apr 2021to Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Rangueil University Hospital
Toulouse, 31059
Barbara Bournet, MD, PhD, 5 61 32 32 35 ext. 0033, bournet.b@chu-toulouse.fr
Cindy Canivet, 5 61 32 20 48 ext. 0033, canivet.c@chu-toulouse.fr
About this study
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.
Read the 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.
- Conditions
- Inflammatory Bowel Diseases, Colon Cancer
- Being tested
- blood and intestinal biopsy sampling
- Keywords
- Intestinal Bowel syndrome, Inflammatory Bowel Disease, colon cancer screening, data and biological collection
- Medical subject headings
- Inflammatory Bowel Diseases, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood and intestinal biopsy samplingBiological
24 mL of blood and 10 intestinal biopsies will be sampled
| Study group | Role | What they receive |
|---|---|---|
| Patient screened or followed-up for IBS or IBD or colorectal cancer | Blood and colon biopsy sampling Receives: Biological: blood and intestinal biopsy sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
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
Measured: pre-intervention/procedure/surgery
Secondary outcomes (2)
Identify new potential therapeutic molecules
Assessment of new treatment on organoids made thanks to intestinal biopsies
Measured: Baseline
Optimize treatment success rates for IBD
Assessment of new treatment on organoids made thanks to intestinal biopsies
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start29 Apr 2021
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara Bournet, MD, PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896684
- Sponsor's protocol ID
- RC31/21/0038
- Acronym
- CAPITOL
- Status last verified
- Jun 2024
- First submitted
- 3 May 2021
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Intestinal Pathologies Analytical Cohort at TouLouse
- ClinicalTrials.gov ID
- NCT04896684
- Acronym / sponsor ID
- CAPITOL / RC31/21/0038
- Conditions
- Inflammatory Bowel Diseases, Colon Cancer
- Keywords
- Intestinal Bowel syndrome, Inflammatory Bowel Disease, colon cancer screening, data and biological collection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 21 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient screened or followed-up for IBS or IBD or colorectal cancer | – | Biological: blood and intestinal biopsy samplingBlood and colon biopsy sampling |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood and intestinal biopsy sampling24 mL of blood and 10 intestinal biopsies will be sampled | Biological | Patient screened or followed-up for IBS or IBD or colorectal cancer |
Primary outcome
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
2 secondary outcomes
Identify new potential therapeutic molecules
Time frame: Baseline
Optimize treatment success rates for IBD
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Bournet, MD, PhD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Colon Cancer, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbara Bournet, MD, PhD (5 61 32 32 35 ext. 0033, bournet.b@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biological collection associated with clinical data (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.