Using videocapsule endoscopy to detect small bowel cancer in Lynch syndrome patients
Official title: Role of Videocapsule Endoscopy in Lynch Syndrome: a Multicenter Italian Registry Study
Run by San Raffaele University · NCT05704010 · Data updated 2026-11-12
This study is testing whether a tiny camera capsule can help find small bowel cancer in people with Lynch syndrome.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | San Raffaele University Academic / other |
| Locations | 1 site (Milan, Lombardy) |
| Status | Recruiting |
| Started | November 1, 2018 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2029 |
| Registry record updated | April 22, 2026 |
| Trial ID | NCT05704010 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults with a pathogenic germline variant in one of the mismatch repair genes associated with Lynch syndrome.
✕Probably not a fit
Patients under 18 years of age or those with prior small bowel surgery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the incidence of neoplasia and preneoplastic lesions in the small bowel of patients with Lynch syndrome using videocapsule endoscopy (VCE). Lynch syndrome is associated with a significantly increased risk of small bowel cancer due to pathogenic variants in mismatch repair genes. The VCE involves swallowing a capsule with a camera that captures images of the gastrointestinal tract, which are then analyzed to identify potential cancers. This multicentric observational study will collect prospective data without altering the current standard of care.
Why it matters
Potential benefit: If successful, this study could improve early detection of small bowel cancer in patients with Lynch syndrome, potentially leading to better outcomes.
How similar studies have gone: While there is conflicting evidence regarding the efficacy of small bowel cancer screening with VCE, this study aims to provide new insights into its effectiveness for Lynch syndrome patients.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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San Raffaele Scientific Institute, Gastroenterology and Gastrointestinal Endoscopy Unit
Milan, Lombardy, Italy Recruiting
Study contacts
- Study coordinator: Giulia Martina Cavestro, MD PhD
- Email: cavestro.giuliamartina@hsr.it
- Phone: +390226437217
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.