Small Bowel Capsule Endoscopy for (Pre)Neoplastic Lesion Screening in Patients With Lynch Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
Brief 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:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
Time Frame: At the end of the study (12 month)
Diagnostic performance of index SBCE
Secondary Outcomes
- Diagnostic performance of subsequent SBCE(At the end of the study (12 month))
- Age at diagnosis of small bowel (pre)neoplastic lesions(At the end of the study (12 month))
- Frequency of small bowel (pre)neoplastic lesions found by SBCE in patients with LS depending on the type of pathogenic DNA mismatch repair gene variants.(At the end of the study (12 month))
- Type of treatment of any lesion of (pre)neoplastic appearance of the small bowel detected by SBCE.(At the end of the study (12 month))
- Post-therapeutic follow-up(At the end of the study (12 month))
- Proportion of adverse events during SBCE(At the end of the study (12 month))
- Completeness rate to evaluate technical performances of SBCE(At the end of the study (12 month))
- Small bowel recording duration to evaluate technical performances of SBCE(12 months)
- Recourse to endoscopic techniques (duodenal release) when the capsule cannot be ingested or ingestion has failed to evaluate technical performances of SBCE(12 months)