Small Bowel Capsule Endoscopy in Lynch Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Absence of documented MMR gene variant
Opposition to the study
Trial population
Patients carrying a pathogenic variant of the DNA mismatch repair gene (MMR) (MLH1, MSH2, MSH6, PMS2, EPCAM) with at least one SBCE for screening of small bowel (pre)neoplastic lesions over the study period (Jan 1st 2000 - Dec 31st 2024),
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
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
Diagnostic performance of index SBCE
Time frame
At the end of the study (12 month)Secondary outcomes
1
Proportion of adverse events during SBCE
Time frame
At the end of the study (12 month)2
Completeness rate to evaluate technical performances of SBCE
completeness rate is the entire small bowel visualized, depending on past surgical history
Time frame
At the end of the study (12 month)3
Small bowel recording duration to evaluate technical performances of SBCE
Time frame
12 months4
Recourse to endoscopic techniques (duodenal release) when the capsule cannot be ingested or ingestion has failed to evaluate technical performances of SBCE
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov