NCT07472686

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Jun 2025Dec 2026

Study Start

First participant enrolled

June 16, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

12 months

First QC Date

February 27, 2026

Last Update Submit

March 11, 2026

Conditions

MMR MutationSmall Bowel AdenomaSmall-bowel AdenocarcinomaLynch SyndromeCancer

Keywords

CancerLynch syndromeCapsule endoscopyScreeningSmall bowelSmall-bowel adenomaSmall-bowel adenocarcinomaSmall-bowel cancerSmall-bowel capsule endoscopypathogenic variantDNA mismatch repair gene (MMR)MLH1MSH2MSH6PMS2EPCAM

Outcome Measures

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

    At the end of the study (12 month)

Secondary Outcomes (9)

  • 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

  • Diagnostic performance of subsequent SBCE

    At the end of the study (12 month)

  • +4 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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),

You may qualify if:

  • 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

You may not qualify if:

  • Absence of documented MMR gene variant
  • Opposition to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Digestive Endoscopy, Saint-Antoine Hospital

Paris, France

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms, Hereditary NonpolyposisNeoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplastic Syndromes, HereditaryDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDNA Repair-Deficiency DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Xavier DRAY, MD PhD

CONTACT

+33 (0) 1 49 28 21 61xavier.dray@aphp.fr

Aymeric BECQ, MD

CONTACT

+33 (0) 1 49 81 23 55aymeric.becq@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2026

First Posted

March 16, 2026

Study Start

June 16, 2025

Primary Completion

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)