Evaluation of the CAD-EYE System for the Detection of Colorectal Neoplastic Lesions in Patients With Lynch Syndrome

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Hôpital Européen Georges-Pompidou HEGP
RECRUITING
Paris
Contact Information
Primary
Guillaume Perrod, MD
guillaume.perrod@aphp.fr
+33 1 56 09 34 17
Time Frame
Start Date: 2024-04-18
Estimated Completion Date: 2026-04-18
Participants
Target number of participants: 272
Treatments
Experimental: CAD-EYE group: Colorectal cancer screening with CAD EYE colonoscopy
The colonoscopy procedure for each patient will be no different from a conventional colonoscopy examination. In the CAD EYE group, descent is performed under white light, with the CAD EYE system switched on (device with CE mark). When polyps are detected, they are rigorously described and histological predictions of endoscopist and CAD EYE will be reported separately.
No_intervention: CE group : Colorectal cancer screening with indigo carmine chromo colonoscopy
The colonoscopy procedure for each patient will be no different from a conventional colonoscopy examination. In the CE group, descent is performed under white light with indigo carmin chromoendoscopy (0.4%) applied through a catheter spray. When polyps are detected, they are rigorously described and histological prediction of the endoscopist reported.
Sponsors
Leads: PERROD Guillaume

This content was sourced from clinicaltrials.gov