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Clinical Trials/JPRN-jRCT1032230396
JPRN-jRCT1032230396
Recruiting
Phase 3

A multicenter randomized controlled trial to assess the usefulness of computer-aided detection systems for colonoscopy in colorectal cancer screening in the Asia-Pacific region - NCCH2217

Saito Yutaka0 sites1,400 target enrollmentOctober 16, 2023

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
Saito Yutaka
Enrollment
1400
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 16, 2023
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Saito Yutaka

Eligibility Criteria

Inclusion Criteria

  • 1\) Individuals who are scheduled to undergo total colonoscopy for either reason a) or b).
  • a) Primary screening colonoscopy for CRC screening
  • b) Further colonoscopy due to positive fecal immunochemical test (FIT) upon CRC screening
  • 2\) Age at entry is between 50 and 79 years.
  • 3\) ECOG Performance status is 0 or 1\.
  • 4\) Written consent to participate in the study has been obtained.

Exclusion Criteria

  • 1\) Individuals with poorly controlled complications (including unstable angina, post\-acute myocardial infarction, heart failure, chronic respiratory disease, bleeding tendency) that make it difficult to safely perform colonoscopy.
  • 2\) When pathological diagnosis of colorectal lesions is not possible due to reasons such as being on antithrombotic medication and being unable to withdraw the medication
  • 3\) Clinically suspicious symptoms of CRC, such as bloody stools or abdominal pain
  • 4\) History of CRC treatment
  • 5\) History of colorectal surgery involving bowel resection of the colon or rectum (history of surgery not involving bowel resection of the colon or rectum, such as appendectomy for appendicitis, is acceptable)
  • 6\) Family history of hereditary CRC
  • 7\) Have or have had inflammatory bowel disease
  • 8\) Colorectal polyposis
  • 9\) Have had a colonoscopy within 5 years before the date of registration
  • 10\) Other cases deemed inappropriate by the doctor in charge

Outcomes

Primary Outcomes

Not specified

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