Capsule camera screening of the small intestine for people with Lynch syndrome
Official title: Small Bowel Capsule Endoscopy for (Pre)Neoplastic Lesion Screening in Patients With Lynch Syndrome
Run by Assistance Publique - Hôpitaux de Paris · NCT07472686 · Data updated 2026-11-12
This project looks back at past small-bowel capsule endoscopy exams to see if they detect precancerous lesions or early cancer in people with Lynch syndrome.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | June 16, 2025 |
| Main results expected | June 2026 |
| Study ends | December 2026 |
| Registry record updated | March 16, 2026 |
| Trial ID | NCT07472686 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people with Lynch syndrome confirmed by a pathogenic MMR gene variant who had at least one small-bowel capsule endoscopy and did not oppose reuse of their clinical data.
✕Probably not a fit
People without a documented pathogenic MMR variant, those who never had capsule endoscopy at a participating center, or those who refuse reuse of their healthcare data would not be included and are unlikely to benefit directly.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The iCARE4Lynch project is a retrospective cohort of people carrying a pathogenic MMR gene variant who underwent at least one small-bowel capsule endoscopy between January 1, 2000 and December 31, 2024. The primary aim is to estimate how well a first (index) capsule endoscopy detects small-bowel precancerous and cancerous lesions, while recording technical performance and adverse events. Secondary analyses include the performance of subsequent capsule exams, age at lesion diagnosis, therapeutic impact of detected lesions, and lesion frequency by specific MMR gene. Data come from routine clinical records at participating iCARE centers and no additional procedures are required for participants.
Why it matters
Potential benefit: If positive, the findings could help doctors detect small-bowel precancers earlier in people with Lynch syndrome and inform better screening recommendations.
How similar studies have gone: Capsule endoscopy is proven for detecting small-bowel lesions in other clinical contexts, but its specific usefulness for screening people with Lynch syndrome is limited and not well established.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Center for Digestive Endoscopy, Saint-Antoine Hospital
Paris, France Recruiting
Study contacts
- Study coordinator: Xavier DRAY, MD PhD
- Email: xavier.dray@aphp.fr
- Phone: +33 (0) 1 49 28 21 61
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.