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

niversitätsklinikum Bonn0 个研究点目标入组 764 人开始时间: 2023年1月17日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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

•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

发起方

niversitätsklinikum Bonn