Using CAD-EYE for detecting cancer lesions in Lynch syndrome patients
Evaluation of the CAD-EYE System for the Detection of Colorectal Neoplastic Lesions in Patients With Lynch Syndrome
This study tests if using the CAD-EYE system during colonoscopies can help find cancer lesions better in people with Lynch syndrome compared to regular methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 272 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | French Society of Digestive Endoscopy Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT05963191 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of the CAD-EYE system in enhancing the detection of neoplastic lesions during colorectal cancer screening in patients with Lynch syndrome. Lynch syndrome significantly increases the risk of colorectal cancer, making effective screening crucial. The study aims to compare the adenoma detection rate using CAD-EYE colonoscopy versus traditional methods. Participants will undergo colonoscopy with the CAD-EYE system to evaluate its potential benefits in improving cancer detection rates.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with confirmed pathogenic mutations associated with Lynch syndrome.
Not a fit: Patients who have undergone total colectomy or have a history of inflammatory bowel disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier and more accurate detection of colorectal cancer in patients with Lynch syndrome.
How similar studies have performed: While the use of artificial intelligence in colonoscopy is emerging, this specific application of CAD-EYE in Lynch syndrome patients is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed pathogenic mutation (path\_MLH1, path\_MSH2, path\_MSH6, path\_PMS2, path\_EpCAM) * Male or female of legal age at time of colonoscopy prescription. * Patient agreeing to participate in the study * Person affiliated with or benefiting from a social security scheme * Free, informed and express consent Exclusion Criteria: * Patient undergoing total colectomy with ileoanal or ileosigmoid anastomosis * Patient with a history of Crohn's disease or ulcerative colitis * Patients with a known allergy or intolerance to polyethylene glycol and ascorbic acid. * Patients unable to undergo fractionated colonic preparation * Inadequate colonic preparation: Boston sub-score \<2 per segment * Patient under guardianship or protected person * Patient who does not understand French or cannot read * Person not affiliated to a Social Security system. * Pregnant women
Where this trial is running
Paris
- Hôpital Européen Georges-Pompidou HEGP — Paris, France (Recruiting)
Study contacts
- Study coordinator: Guillaume Perrod, MD
- Email: guillaume.perrod@aphp.fr
- Phone: +33 1 56 09 34 17
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.