Preclinical Evaluation of Multimodal Therapeutic Strategies in Intestinal Irradiation and Inflamm… (NCT05425901) | Clinical Trial Compass
CompletedNot Applicable
Preclinical Evaluation of Multimodal Therapeutic Strategies in Intestinal Irradiation and Inflammatory Bowel Disease From Organoids
France16 participantsStarted 2022-09-19
Plain-language summary
This study is carried out in patients with IBD and healthy subjects requiring ileocolonoscopy as part of routine care (disease monitoring or polyp/colon cancer screening). It aims the generation and culturing of organoids from digestive biopsies recovered from healthy and/or pathological (inflammatory) ileal and/or colonic mucosa during an ileo-colonoscopy. These cultures will make it possible to validate the organoid production method used in the context of the research (primary objective). In a second phase (secondary objectives), the study will aim to setup a screening tool by irradiating the organoids (step one) and then evaluate in vitro the regenerative activity of treatments dedicated to improve inflammatory bowel diseases and acute radiation enteritis (step two).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
\- Group 1: active IBD
* 18 years old or older
* Assured IBD diagnosis (Crohn's disease/ulcerative colitis) according to European Crohn's and Colitis Organisation (ECCO) 2019 consensus criteria
* Active IBD (Harvey-Bradshaw score of 4 or above for Crohn's disease or partial Mayo score of 3 or above for ulcerative colitis)
* Indication to perform a coloscopy
* Written consent for study participation obtained
Or
\- Group 2: inactive IBD
* 18 years old or older
* Assured IBD diagnosis (Crohn's disease/ulcerative colitis) according to ECCO 2019 consensus criteria
* Inactive IBD (Harvey-Bradshaw score below 4 for Crohn's disease or partial Mayo score below 3 for ulcerative colitis)
* Indication to perform a coloscopy
* Written consent for study participation obtained
Or
\- Group 3: Control
* 18 years old or older
* Indication to perform a coloscopy to detect polyp
* No known bowel disease
* Written consent for study participation obtained
Exclusion Criteria:
* Inability to understand, read, sign informed consent and/or express consent
* Person subject to legal protection (curator, guardianship or safeguard of justice),
* Deprivation of liberty by judicial or administrative decision,
* Non-affiliation to a social security scheme or non-beneficiary of such a scheme
* Pregnant, parturient, breastfeeding women
* Contraindication to performing biopsies
* Participation in other therapeutic research that may modify the behavior of intestinal cells (for examp…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Validation of organoid-production method - quantity
Timeframe: Day 1
2
Validation of organoid-production method - size
Timeframe: Day 1
3
Validation of organoid-production method - cell growth
Timeframe: Day 1
4
Validation of organoid-production method - cell composition
Timeframe: Day 1
5
Validation of organoid-production method - cell composition
Timeframe: Day 1
6
Validation of organoid-production method - cell apoptosis
Timeframe: Day 1
7
Validation of organoid-production method - tight junctions
Timeframe: Day 1
Trial details
NCT IDNCT05425901
SponsorInstitut National de la Santé Et de la Recherche Médicale, France