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Clinical Trials/DRKS00030695
DRKS00030695
Recruiting
未知

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 sites764 target enrollmentJanuary 17, 2023

Overview

Phase
未知
Intervention
Not specified
Conditions
Z80.0
Sponsor
niversitätsklinikum Bonn
Enrollment
764
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 17, 2023
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversitätsklinikum Bonn

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:
  • 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

Outcomes

Primary Outcomes

Not specified

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