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

RecruitingNAAges 18 Years - 90 YearsAllPERROD Guillaume
NCT05963191 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 techni

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📋 Eligibility rules (as published)
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
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What it tests

  • Colorectal cancer screening with CAD EYE colonoscopy
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Where

1 site
Hôpital Européen Georges-Pompidou HEGP
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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