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Clinical Trials/DRKS00023157
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

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.

Registry
who.int
Start Date
December 9, 2020
End Date
December 30, 2021
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Medizinische Klinik und Poliklinik I Abteilung Innere Medizin I Universitätsklinikum 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:
  • 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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