Videocapsule Endoscopy in Lynch Syndrome
Recruiting now · Not applicable
Conditions studied: Lynch Syndrome, Lynch Syndrome I, Lynch Syndrome II, MLH1 Gene Mutation, MSH2 Gene Mutation, MSH6 Gene Mutation, PMS2 Gene Mutation, Small Bowel Adenocarcinoma
In brief
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.
Key facts
- Study ID
- NCT05704010
- Run by
- San Raffaele University
- People needed
- 100
- Starts
- 2018-11-01
- Expected to finish
- 2029-12-31
- Last updated by the study team
- 2026-04-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Pathogenic germline variant in one of the MMR genes (MLH1, MSH2/Epcam, MSH6, or PMS2).
You may not qualify if…
- Patients younger than 18 years of age
- Patients unwilling or unable to provide informed consent
- Patients with prior small bowel surgery
- Patients with a contraindication to VCE
Where it is running
- San Raffaele Scientific Institute, Gastroenterology and Gastrointestinal Endoscopy Unit — Milan, Lombardy, Italy (enrolling)
Full record on ClinicalTrials.gov
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