Small Bowel Capsule Endoscopy in Lynch Syndrome (NCT07472686) | Clinical Trial Compass
RecruitingNot Applicable
Small Bowel Capsule Endoscopy in Lynch Syndrome
France400 participantsStarted 2025-06-16
Plain-language summary
The impact of small bowel (SB) capsule endoscopy (CE) on the screening (followed by diagnosis and treatment) of (pre)neoplastic lesions of the small bowel in Lynch syndrome (LS) patients is unknown.
The iCARE4Lynch study is a retrospective cohort of patients carrying a pathogenic variant of the DNA mismatch repair gene (MMR) (MLH1, MSH2, MSH6, PMS2, EPCAM) who had had at least one SBCE for screening of small bowel (pre)neoplastic lesions between January 1st 2000 and December 31 2024.
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:
* Patient carrying a pathogenic variant of the DNA mismatch repair gene (MMR) (MLH1, MSH2, MSH6, PMS2, EPCAM)
* Capsule endoscopy screening for (pre)neoplastic lesions of the small intestine
* No opposition to the reuse of healthcare data for research purposes
Exclusion Criteria:
* Absence of documented MMR gene variant
* Opposition to the study
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
proportion of patients in whom at least one small bowel pre-neoplastic (low or high grade adenoma) or neoplastic (adenocarcinoma) lesion, secondarily proven during follow-up, was identified, compared to the total number of patients with index CE in this