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NCT05704010Recruiting

Videocapsule Endoscopy in Lynch Syndrome

Role of Videocapsule Endoscopy in Lynch Syndrome: a Multicenter Italian Registry Study

Source: ClinicalTrials.gov · Last updated 22 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
100 (estimated)
First submitted
13 Jan 2023
Start date
Nov 2018
Primary completion date
Dec 2028
Lead sponsor
San Raffaele University
NCT number
NCT05704010

What you commit to

  • Study type: Interventional
  • Planned participants: 100
  • From Nov 2018 to the primary completion date, Dec 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with prior small bowel surgery

Age

  • Patients younger than 18 years of age

Other

  • Patients unwilling or unable to provide informed consent
  • Patients with a contraindication to VCE

Who the study is looking for

  • Pathogenic germline variant in one of the MMR genes (MLH1, MSH2/Epcam, MSH6, or PMS2).

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
San Raffaele Scientific Institute, Gastroenterology and Gastrointestinal Endoscopy Unit
Coordinator of this site? Confirm its status
MilanItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.