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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)

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

Saito Yutaka

National Cancer Center Hospital, Japan

5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan

ncch2217_office@ml.res.ncc.go.jp

Sekiguchi Masau

National Cancer Center Hospital, Japan

5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan

+81-3-3542-2511

ncch2217_office@ml.res.ncc.go.jp

Recruiting

Dec. 25, 2023

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

diagnostic purpose

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.

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

Both

Patients who receive colonoscopy for colorectal cancer screening

For enrollment, the standard test group and the test group are randomly assigned by the allocation system.
In the test methods, such CADe devices as EndoBRAIN-EYE (Olympus, Cybernet Systems), ENDO-AID (Olympus), WISE VISION (NEC), CAD EYE (FUJIFILM), which have been approved under the regulations of each country are used. The colonoscopy procedure is similar to the standard examination method, except that CADe assists endoscopists in detecting lesions during colonoscopy. CADe is activated during colonoscopy to alert candidates for polyps, cancer, and other lesions in real time. Different countries and regions have different regulatory approvals for different models.
The standard examination method is a conventional colonoscopy without CADe.

Adenoma detection rate (ADR)

1) Adenomas per colonoscopy (APC)
2) Detection rate and number of advanced adenomas
3) Detection rate and number of colorectal neoplastic lesions other than adenomas, such as colorectal cancer (CRC) and colorectal serrated lesions
4) Detection rate and number of flat and depressed tumors
5) Colonoscopy examination time (time for scope insertion (from the anus to the cecum) and time for scope withdrawal from the cecum to the anus)
6) Incidence of adverse events
7) Resection rate and number of non-neoplastic polyps in the large intestine
8) Proprotion of sedative usage

+81-3-3542-2511

Sept. 11, 2023

No

South Korea/Taiwan/Singapore/Hong Kong/Thailand