Actively Recruiting
Evaluation of the CAD-EYE System for the Detection of Colorectal Neoplastic Lesions in Patients With Lynch Syndrome
Led by PERROD Guillaume · Updated on 2025-09-03
272
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Lynch syndrome is the most common genetic condition that increases the risk of colorectal cancer. It results from mutations in specific DNA repair genes and leads to a high chance of developing colorectal cancer at a young age. Regular colonoscopy screenings are important for early detection and reducing cancer risk. This trial aims to compare a new artificial intelligence tool called the CAD EYE system with a traditional method called indigo carmine chromoendoscopy for detecting colorectal lesions in patients with Lynch syndrome. Participants will undergo colonoscopy screening using either the CAD EYE system or indigo carmine chromoendoscopy. In the CAD EYE group, the colonoscopy is performed with white light and the CAD EYE device activated to help detect polyps, which are then described and removed for analysis. In the chromoendoscopy group, indigo carmine dye is applied during the colonoscopy to highlight lesions, which are also described and removed if found. Both methods follow standard colonoscopy procedures. During the study, participants will have their colonoscopy results carefully recorded, including lesion detection rates, diagnostic performance of the CAD EYE system, and procedure times. Researchers will monitor outcomes over about two years to assess the effectiveness of the CAD EYE system in screening for neoplastic lesions in Lynch syndrome. Safety, accuracy, and procedural details will be evaluated to understand the tool's potential role in clinical practice.
CONDITIONS
Brief Title
CAD-EYE System for the Detection of Neoplastic Lesions in Patients With Lynch Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed pathogenic mutation in MLH1, MSH2, MSH6, PMS2, or EpCAM
- Male or female of legal age at time of colonoscopy prescription
- Patient agrees to participate in the study
- Person affiliated with or benefiting from a social security scheme
- Free, informed, and express consent
You will not qualify if you...
- Patient who had total colectomy with ileoanal or ileosigmoid anastomosis
- History of Crohn's disease or ulcerative colitis
- Known allergy or intolerance to polyethylene glycol and ascorbic acid
- Unable to undergo fractionated colonic preparation
- Inadequate colonic preparation with Boston sub-score less than 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo a colonoscopy procedure with either the CAD EYE system or indigo carmine chromoendoscopy to detect colorectal neoplastic lesions. Detected polyps are described and removed when applicable.
1 colonoscopy visit (in-person)
Duration - Up to 2 years
Participants are monitored for up to 2 years to evaluate the effectiveness of the CAD EYE system and other diagnostic outcomes.
Follow-up visits as scheduled by the study team
Trial Site Locations
Total: 1 location
1
Hôpital Européen Georges-Pompidou HEGP
Paris, France, 75015
Actively Recruiting
Research Team
G
Guillaume Perrod, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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