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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство Colorectal cancer screening with CAD EYE colonoscopy
  The colonoscopy procedure for each patient will be no different from a conventional colonoscopy examination. A colonoscopy is considered complete if the endoscope reaches the appendicular orifice or the terminal ileum. In line with recommendations, water lavage (using a lavage pump) and aspiration of food residues will be performed on ascent and/or descent to visualize the entire colonic mucosa. In the CAD EYE group, descent is performed under white light, with the CAD EYE system switched on. W

Первичные конечные точки

• to evaluate the effectiveness of the CAD EYE system in screening for neoplastic lesions in Lynch syndrome. [Срок оценки: Through study completion, an average of 2 years]

Вторичные конечные точки (4)

• Detection rates of specific lesions [Срок оценки: Through study completion, an average of 2 years]
• Diagnostic performance of CAD EYE [Срок оценки: Through study completion, an average of 2 years]
• Rate of resect and discard strategy [Срок оценки: Through study completion, an average of 2 years]
• Time of Colonoscopies [Срок оценки: Through study completion, an average of 2 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Диагностика

Центры проведения

Франция · 1 центр

• Hôpital Européen Georges-Pompidou HEGP — Paris

Идентификаторы

NCT: NCT05963191 · SFED 156

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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