NCT07472686

Small Bowel Capsule Endoscopy in Lynch Syndrome

Small Bowel Capsule Endoscopy for (Pre)Neoplastic Lesion Screening in Patients With Lynch Syndrome

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Population study Participating investigators Members of the international CApsule endoscopy REsearch (iCARE) group Objectives The primary objective of the study is to estimate the diagnostic performance of a first (index) SB CE for screening of small bowel (pre)neoplastic lesions in patients with LS. Secondary objectives are to estimate, in this setting: * the frequency and type of adverse events related to the performance of SB CE; * the technical performances of SB CE; * diagnostic performance of subsequent SB CEs; * the age at diagnosis of SB (pre)neoplastic lesions * the therapeutic impact of CE detection of SB lesions * the frequency of SB (pre)neoplastic lesions found, depending on the type of pathogenic DNA mismatch repair gene variants. Origin of personal health data (source(s) used) This research focuses on the analysis of data collected as part of the routine clinical care of patients (no additional examination will be requested). Data will be collected from patient medical records (paper and digital). Personal data circuit and method for protecting the confidentiality of personal data The personal data circuit concerns the use of care data from capsule endoscopy (CE) examination reports in paper files or stored in the Orbis software present in the APHP computer network or the CE software of each associated hospital center. A correspondence table with order numbers will be used. There will be no circulation or exchange of data. Access to the data is secured at the APHP network and the data will be archived for 15 years in the coordinating center. Information concerning deceased persons, including that which appears on death certificates, may be processed for research, study or health evaluation purposes, unless the patient has, during his or her lifetime, expressed his or her written refusal. The vital status of patients will be investigated before data collection (alive or deceased). Variables and analysis Patient data: Age at SBCE; Gender; Pathogenic variant of MMR gene; History of LS-related cancer; History and type of digestive surgery; First-degree family history (parents, siblings, children) of small bowel adenocarcinoma; Indication for SBCE: screening, family history, clinical or radiological diagnosis; Timing and organization of the study, research or evaluation: Data collected from January 1st 2000 to December 31st 2024. Total study duration: 12 months

Conditions

• MMR Mutation
• Small Bowel Adenoma
• Small-bowel Adenocarcinoma
• Lynch Syndrome
• Cancer

Timeline

• Start date: 2025-06-16
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2026-03-16
• Last updated: 2026-03-16

Locations

1 site across 1 country: France