Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT05704010

Videocapsule Endoscopy in Lynch Syndrome

Led by San Raffaele University · Updated on 2026-04-22

100

Participants Needed

1

Research Sites

582 weeks

Total Duration

On this page

Sponsors

S

San Raffaele University

Lead Sponsor

U

Unita' di Gastroenterologia - Policlinico Universitario di Bari

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Videocapsule Endoscopy in Lynch Syndrome

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pathogenic germline variant in one of the mismatch repair genes (MLH1, MSH2/Epcam, MSH6, or PMS2)
Not Eligible

You will not qualify if you...

  • Younger than 18 years of age
  • Unable or unwilling to provide informed consent
  • Prior small bowel surgery
  • Contraindication to video capsule endoscopy

AI-Screening

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Trial Site Locations

Total: 1 location

1

San Raffaele Scientific Institute, Gastroenterology and Gastrointestinal Endoscopy Unit

Milan, Lombardy, Italy, 20132

Actively Recruiting

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Research Team

G

Giulia Martina Cavestro, MD PhD

CONTACT

M

Marta Puzzono, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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