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

NCT05963191 | Recruiting

• 1 other identifier: SFED 156
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 1

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.

Conditions

Lynch Syndrome

Keywords

Lynch Syndrome; CAD EYE; adenoma detection rate; colorectal screening; artificial intelligence

Outcome Measures

Primary Outcomes (1)

• to evaluate the effectiveness of the CAD EYE system in screening for neoplastic lesions in Lynch syndrome.

  Comparison of the adenoma detection rate (ADR) between the CAD-EYE group and the indigo carmin chromoendoscopy (CE) group (reference technique).

  Through study completion, an average of 2 years

Secondary Outcomes (4)

• Detection rates of specific lesions

  Through study completion, an average of 2 years

• Diagnostic performance of CAD EYE

  Through study completion, an average of 2 years

• Rate of resect and discard strategy

  Through study completion, an average of 2 years

• Time of Colonoscopies

  Through study completion, an average of 2 years

Study Arms (2)

CAD-EYE group: Colorectal cancer screening with CAD EYE colonoscopy

EXPERIMENTAL

The colonoscopy procedure for each patient will be no different from a conventional colonoscopy examination. In the CAD EYE group, descent is performed under white light, with the CAD EYE system switched on (device with CE mark). When polyps are detected, they are rigorously described and histological predictions of endoscopist and CAD EYE will be reported separately.

Device: Colorectal cancer screening with CAD EYE colonoscopy

CE group : Colorectal cancer screening with indigo carmine chromo colonoscopy

NO INTERVENTION

The colonoscopy procedure for each patient will be no different from a conventional colonoscopy examination. In the CE group, descent is performed under white light with indigo carmin chromoendoscopy (0.4%) applied through a catheter spray. When polyps are detected, they are rigorously described and histological prediction of the endoscopist reported.

Interventions

Colorectal cancer screening with CAD EYE colonoscopy DEVICE

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. When polyps are detected, they are rigorously described and histological predictions of endoscopist and CAD EYE will be reported separately. Then polyps will be removed by polypectomy or mucosectomy. Removed polyps are then sent for anatomopathological analysis.

CAD-EYE group: Colorectal cancer screening with CAD EYE colonoscopy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PERROD Guillaume: lead

Study Sites (1)

Hôpital Européen Georges-Pompidou HEGP

Paris, 75015, France

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms, Hereditary Nonpolyposis

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Guillaume Perrod, MD

CONTACT

+33 1 56 09 34 17; guillaume.perrod@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Medical Doctor

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 27, 2023
• Study Start: April 18, 2024
• Primary Completion: April 18, 2025
• Study Completion: April 18, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-09

Locations

FR (1)