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Real-time use of artificial intelligence (CADEYE) in the colo-rectal cancer surveillance of Lynch syndrome patients (CADLY) - CADLY

Medizinische Klinik und Poliklinik I Abteilung Innere Medizin I Universitätsklinikum Bonn0 个研究点目标入组 101 人开始时间: 2020年12月9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:
•Proven presence of a pathogenic germline variant in MLH1, MHS2 or MSH6 (Lynch Syndrome)
•Interval to last colonoscopy 10-36 months

•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 another clinical trial or participation in any clinical trial involving administration of an investigational medicinal product within 30 days prior to clinical trial beginning
•Screening laboratory test results within the following parameters (if 1 or more of the laboratory parameters is out of range, a single retest of laboratory values is permitted during the approximately 4-week screening period):
•o Quick >50%,
•o Thrombocytes >50.000 G/l
•Exclusion criteria regarding special restrictions for females:
•Current or planned pregnancy or nursing women
•Negative pregnancy test in women with child-bearing potential
•Indication specific exclusion criteria:
•Previous extensive colorectal surgery (proctocolectomy or colectomy with ileorectal anastomosis)
•Index colonoscopy
•Insufficient bowel preparation (Boston score of <2 by colonic segment)

发起方

Medizinische Klinik und Poliklinik I Abteilung Innere Medizin I Universitätsklinikum Bonn