Clinical trial NCT05963191: CAD-EYE System for the Detection of Neoplastic Lesions in Patients With Lynch Syndrome
Official title: Evaluation of the CAD-EYE System for the Detection of Colorectal Neoplastic Lesions in Patients With Lynch Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lynch Syndrome
Keywords: Lynch Syndrome
CAD EYE
adenoma detection rate
colorectal screening
artificial intelligence
Lead sponsor: French Society of Digestive Endoscopy
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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 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.


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

Primary outcomes:
measure: to evaluate the effectiveness of the CAD EYE system in screening for neoplastic lesions in Lynch syndrome.
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Detection rates of specific lesions
timeFrame: Through study completion, an average of 2 years
measure: Diagnostic performance of CAD EYE
timeFrame: Through study completion, an average of 2 years
measure: Rate of resect and discard strategy
timeFrame: Through study completion, an average of 2 years
measure: Time of Colonoscopies
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Européen Georges-Pompidou HEGP
Study officials:
References: