Status:

RECRUITING

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

Lead Sponsor:

PERROD Guillaume

Conditions:

Lynch Syndrome

Eligibility:

All Genders

18-90 years

Phase:

NA

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

April 18 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 18 2026

Estimated Enrollment :

272 Patients enrolled

Trial Details

Trial ID

NCT05963191

Start Date

April 18 2024

End Date

April 18 2026

Last Update

September 3 2025

Active Locations (1)

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Hôpital Européen Georges-Pompidou HEGP

Paris, France, 75015