Real-time use of artificial intelligence (CAD EYE) in the colorectal cancer surveillance of Lynch syndrome patients (CADLYII) – an international multicenter trial

Not Applicable

Recruiting

• Conditions: Z80.0; Family history of malignant neoplasm of digestive organs

• Registration Number: DRKS00030695
• Lead Sponsor: niversitätsklinikum Bonn

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 764

Inclusion Criteria

General inclusion criteria:
Age =18 years
Written informed consent of the subject for voluntary participation in the study
Subjects with the ability to follow study instructions and likely to attend and complete all required visits
Indication-specific inclusion criteria:
Diagnosis of Lynch-syndrome (presence of a (likely-) pathogenic germline variant in MLH1, MSH2, MSH6, PMS2; deletion in the 3` region of the EPCAM gene)
Surveillance colonoscopy

Exclusion Criteria

General exclusion criteria:
Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this study
Patients with a physical or psychiatric condition/ a systemic disease which at the investigator’s discretion may compromise safety of the subject, may confound the trial results, may interfere with the subject’s participation in this clinical study or may prevent sufficient compliance
Simultaneously participation in any clinical trial involving administration of an investigational medicinal product within 30 days prior to clinical trial beginning
Exclusion criteria regarding special restrictions for females:
Current pregnancy
Indication specific exclusion criteria:
Previous extensive colorectal surgery (proctocolectomy or colectomy with ileorectal anastomosis)
Recent surveillance colonoscopy within 12 months from current examination
Symptoms such as rectal bleeding, change in bowel habits, unexplained weight loss, anemia
Concomitant inflammatory bowel disease

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of the adenoma detection rate (ADR) during high-definition white-light endoscopy (HD-WLE) with versus without real-time automated detection (CAD EYE Fujifilm)