NCT05963191 CAD-EYE System for the Detection of Neoplastic Lesions in Patients With Lynch Syndrome
| NCT ID | NCT05963191 |
| Status | Recruiting |
| Phase | — |
| Sponsor | PERROD Guillaume |
| Condition | Lynch Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 272 participants |
| Start Date | 2024-04-18 |
| Primary Completion | 2025-04-18 |
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 272 participants in total. It began in 2024-04-18 with a primary completion date of 2025-04-18.
⚠ 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
Lynch syndrome (LS) is the most common genetic predisposition syndrome for colorectal cancer (CRC), responsible for around 2-4% of cancers. It is characterized by a pathogenic germline mutation in one of the DNA mismatch repair genes (path\_MMR) MLH1, MSH2, MSH6, PMS2 or a deletion in the 3' region of the Epcam gene. Patients followed up for LS are at high risk of developing CRC at an early age, and have a high cumulative CRC risk. In this context, CRC screening by colonoscopy is of major importance, as it is associated with a reduction in both CRC incidence and mortality. In France, the Institut National du Cancer (INCa) recommends colonoscopy with indigo carmine chromoendoscopy (CE), as it is associated with a significant increase in the adenoma detection rate (ADR) compared with white light. However, EC is not routinely performed in clinical practice, as it is a time-consuming technique requiring a dedicated slot with a trained operator. Recent years have seen the emergence of artificial intelligence techniques for real-time polyp detection aids or CADe devices. These easy-to-use systems have shown very promising results compared with high-definition (HD) white light. Indeed, data from the first meta-analysis of 5 randomized controlled trials (4354 patients) confirmed a significantly higher ADD in the CADe group than in the HD group (36.6% vs. 25.2%; 95% CI\], 1.27-1.62; P \< 0.01; I2 Z 42%) 10. The CAD EYE system (Fujifilm) is a CADe device supporting both detection (sensitivity \> 95%) and characterization of colonic polyps in real time. To date, artificial intelligence has never been evaluated for CRC screening in patients followed up for LS. The aim of this work is to evaluate the effectiveness of the CAD EYE system in this specific population. To this end, we intend to conduct a randomized, controlled, non-inferiority trial comparing CAD EYE with CE in patients with LS.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05963191 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, 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 NCT05963191 currently recruiting?
Yes, NCT05963191 is actively recruiting participants. Contact the research team at guillaume.perrod@aphp.fr for enrollment information.
Where is the NCT05963191 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT05963191 clinical trial?
NCT05963191 is sponsored by PERROD Guillaume. The trial plans to enroll 272 participants.