Using videocapsule endoscopy to detect small bowel cancer in Lynch syndrome patients
Role of Videocapsule Endoscopy in Lynch Syndrome: a Multicenter Italian Registry Study
This study is testing whether a tiny camera capsule can help find small bowel cancer in people with Lynch syndrome.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | San Raffaele University Academic / other |
| Locations | 1 site (Milan, Lombardy) |
| Trial ID | NCT05704010 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients under 18 years of age or those with prior small bowel surgery may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Milan, Lombardy
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.