Small Bowel Capsule Endoscopy in Lynch Syndrome (iCARE4Lynch)

March 11, 2026 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Recruiting

Conditions

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

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Paris, France
        • Recruiting
        • Center for Digestive Endoscopy, Saint-Antoine Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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),

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At the end of the study (12 month)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of adverse events during SBCE
Time Frame: At the end of the study (12 month)
At the end of the study (12 month)
Completeness rate to evaluate technical performances of SBCE
Time Frame: At the end of the study (12 month)
completeness rate is the entire small bowel visualized, depending on past surgical history
At the end of the study (12 month)
Small bowel recording duration to evaluate technical performances of SBCE
Time Frame: 12 months
12 months
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 months
12 months
Diagnostic performance of subsequent SBCE
Time Frame: At the end of the study (12 month)
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 on a follow up SBCE, compared to the total number of patients with follow-up SBCE in this setting.
At the end of the study (12 month)
Age at diagnosis of small bowel (pre)neoplastic lesions
Time Frame: At the end of the study (12 month)
Age at diagnosis of small bowel (pre)neoplastic lesions in patients with LS, monitored by repeat SBCE;
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.
Time Frame: At the end of the study (12 month)
Diagnostic performance according to genetic 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.
Time Frame: At the end of the study (12 month)
Type of treatment: endoscopic, surgical, pharmacological, abstention or other.
At the end of the study (12 month)
Post-therapeutic follow-up
Time Frame: At the end of the study (12 month)
Post-therapeutic follow-up of any lesion of (pre)neoplastic appearance of the small bowel detected on a SBCE: anatomopathological analysis of any lesion of (pre)neoplastic appearance of the small bowel detected by SBCE, and consequences (cure, recurrence, additional treatments, death).
At the end of the study (12 month)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 27, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP241223

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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