DRKS00023157
Completed
未知
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 sites101 target enrollmentDecember 9, 2020
ConditionsMedDRA - Lynch-Syndrome
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- MedDRA - Lynch-Syndrome
- Sponsor
- Medizinische Klinik und Poliklinik I Abteilung Innere Medizin I Universitätsklinikum Bonn
- Enrollment
- 101
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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:
- •Proven presence of a pathogenic germline variant in MLH1, MHS2 or MSH6 (Lynch Syndrome)
- •Interval to last colonoscopy 10\-36 months
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 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
Outcomes
Primary Outcomes
Not specified
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