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Search / Trial NCT05963191

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

Launched by PERROD GUILLAUME · Jul 18, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Lynch Syndrome Cad Eye Adenoma Detection Rate Colorectal Screening Artificial Intelligence

ClinConnect Summary

This clinical trial is studying a new system called CAD-EYE, which uses artificial intelligence to help detect polyps in the colon of patients with Lynch Syndrome. Lynch Syndrome is a genetic condition that increases the risk of colorectal cancer (CRC), making regular screening very important. The trial aims to see if the CAD-EYE system is as effective as a traditional method called chromoendoscopy, which uses special dye to highlight polyps during a colonoscopy.

To participate in this trial, you need to be an adult with a confirmed genetic mutation related to Lynch Syndrome and agree to take part in the study. It's important that you are able to understand French and have access to a social security scheme. If you join, you can expect to undergo a colonoscopy where either the CAD-EYE system or the traditional method will be used to check for polyps. The goal is to find out if CAD-EYE can help detect polyps just as well, which could improve screening for colorectal cancer in patients with Lynch Syndrome.

Gender

ALL

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

About Perrod Guillaume

Perrod Guillaume is a clinical trial sponsor dedicated to advancing medical research and improving patient outcomes through innovative therapeutic solutions. With a focus on rigorous scientific methodologies and ethical standards, Perrod Guillaume collaborates with healthcare professionals and research institutions to facilitate the development and evaluation of new treatments across various therapeutic areas. Committed to transparency and integrity, the organization prioritizes patient safety and data integrity in all its clinical endeavors, striving to contribute meaningfully to the advancement of healthcare and the well-being of communities worldwide.

Locations

Paris, , France

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported