Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Pathogenic germline variant in one of the mismatch repair genes (MLH1, MSH2/Epcam, MSH6, or PMS2)
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
AI-Powered 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
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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