Clinical trial of colonoscopy using computer-aided detection systems in colorectal cancer screening (Project CAD)

Recruiting

• Conditions: Patients who receive colonoscopy for colorectal cancer screening

• Registration Number: jRCT1032230396
• Lead Sponsor: National Cancer Center Hospital, Japan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-16
• Study Start: 2023-12-28
• Last Update Posted: 2024-01-26

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1400

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

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
-		Adenoma detection rate (ADR)

Secondary Outcome Measures

Name	Time	Method
Detection rate and number of colorectal neoplastic lesions other than adenomas		Detection rate and number of colorectal neoplastic lesions other than adenomas, such as colorectal cancer (CRC) and colorectal serrated lesions
Colonoscopy examination time		Time for scope insertion (from the anus to the cecum) and time for scope withdrawal from the cecum to the anus