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Videocapsule Endoscopy in Lynch Syndrome

NCT05704010 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-22

No results posted yet for this study

Summary

Background Lynch syndrome is caused by a pathogenic variant in one of the four Mismatch Repair genes (MMR): MLH1, MSH2/Epcam, MSH6, or PMS2. These pathogenic variants confer a higher risk of developing colorectal and other cancers, including small bowel cancer. The risk of developing a small bowel adenocarcinoma is about 100 times higher compared to individuals without Lynch syndrome, and the lifetime risk of small bowel cancer is estimated at 4,2%.

The diagnosis of a small bowel cancer depends on videocapsule endoscopy (VCE). This device is swalled so that it can record images of the small bowel, which are then stored on a wearable device for about 8 hours. The capsule is then expelled in the feces while the images are transferred to a computer to be analysed. To date, there is conflicting evidence on the efficacy of small bowel cancer screening with VCE

Rationale: this registry study will collect prospective data from patients with LS undergoing VCE

Aim: evaluate the incidence of neoplastic and pre-neoplastic lesions in patients with LS during a VCE-based small bowel cancer screening study

Design: this is a multicentric, observational study that analyzes data from diagnostic techniques already approved. Patients will not undergo diagnostic procedures beyond what would be recommended by clinical practice.

Conditions

  • Lynch Syndrome
  • Lynch Syndrome I
  • Lynch Syndrome II
  • MLH1 Gene Mutation
  • MSH2 Gene Mutation
  • MSH6 Gene Mutation
  • PMS2 Gene Mutation
  • Small Bowel Adenocarcinoma

Interventions

DEVICE

Video capsule endoscopy

Video capsule endoscopy every 2 years

Sponsors & Collaborators

  • Unita' di Gastroenterologia - Policlinico Universitario di Bari

    collaborator UNKNOWN

  • Unita' di Gastroenterologia - Centro di Riferimento Oncologico di Aviano

    collaborator UNKNOWN

  • Humanitas Hospital, Italy

    collaborator OTHER

  • San Raffaele University

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2028-12-31
Completion
2029-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05704010 on ClinicalTrials.gov