NCT05704010 Videocapsule Endoscopy in Lynch Syndrome
| NCT ID | NCT05704010 |
| Status | Recruiting |
| Phase | — |
| Sponsor | San Raffaele University |
| Condition | Lynch Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2018-11-01 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2018-11-01 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Pathogenic germline variant in one of the MMR genes (MLH1, MSH2/Epcam, MSH6, or PMS2). Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05704010 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lynch Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05704010 currently recruiting?
Yes, NCT05704010 is actively recruiting participants. Contact the research team at cavestro.giuliamartina@hsr.it for enrollment information.
Where is the NCT05704010 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT05704010 clinical trial?
NCT05704010 is sponsored by San Raffaele University. The trial plans to enroll 100 participants.