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

niversitätsklinikum Bonn0 个研究点目标入组 200 人开始时间: 待定最近更新: 2024年4月9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
•- 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 sub-ject, may
•confound the trial results, may interfere with the subject*s par-ticipation 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
•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 exami-nation
•- Symptoms such as rectal bleeding, change in bowel habits, unexplained weight
•loss, anemia
•- Concomitant inflammatory bowel disease

发起方

niversitätsklinikum Bonn