Protocol for 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 (project CAD/NCCH2217).

Journal: Japanese journal of clinical oncology
Published Date: Jul 6, 2025

Abstract

Ensuring the high quality of colonoscopies in colorectal cancer (CRC) screening is essential to reducing CRC. Recently, computer-aided detection systems (CADe) that use artificial intelligence have attracted much attention as potentially useful tools for improving lesion detection in colonoscopy. However, evidence on the efficacy of CADe in CRC screening is lacking. We have planned a multi-national, multi-center, randomized controlled trial in the Asia-Pacific region to assess whether colonoscopy with CADe (test method) yields higher lesion detection (primary endpoint: adenoma detection rate) than colonoscopy without CADe (standard method) in CRC screening populations. The study will include 1400 participants aged 50-79 years who are due to undergo colonoscopy for CRC screening, whether as a primary screening colonoscopy or following a positive fecal immunochemical test. If the efficacy of CADe is proven from this study, the use of CADe in colonoscopy for CRC screening will become standard, leading to improved CRC screening.

Authors

  • Masau Sekiguchi
    Screening Center/Department of Endoscopy, National Cancer Center Hospital, Tokyo, Japan.
  • Kensuke Shinmura
    Department of Gastroenterology and Endoscopy National Cancer Center Hospital East Chiba Japan.
  • Kazuki Sumiyama
    Department of Endoscopy, The Jikei University School of Medicine, Tokyo, Japan.
  • Takahisa Matsuda
    Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan; Cancer Screening Center, National Cancer Center Hospital, Tokyo, Japan.
  • Kyung S Han
    Center for Colorectal Cancer, National Cancer Center, 323 Ilsan-ro, Ilsandong-gu, Goyang-si Gyeonggi-do, 10408, Republic of Korea.
  • Hyun-Soo Kim
    Department of Pathology and Translational Genomics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
  • Han-Mo Chiu
    Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
  • Chi-Yang Chang
    Department of Internal Medicine, Fu Jen Catholic University Hospital, No. 69, Guizi Road, Taishan District, New Taipei City, 24352, Taiwan (R.O.C.).
  • Wei J J Lee
    Division of Gastroenterology and Hepatology, National University Hospital, 1E Kent Ridge Road, #13-00, 119228, Singapore.
  • Christopher J L Khor
    Department of Gastroenterology and Hepatology, Singapore General Hospital, 20 College Road, Academia, Level 3, S169856, Singapore.
  • Louis H-S Lau
    Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, 9/F Clinical Sciences Building, Shatin, New Territories,Hong Kong, SAR.
  • Sukit Pattarajierapan
    Surgical Endoscopy Colorectal Division, Department of Surgery, Faculty of Medicine, Chulalongkorn University, 1873 Rama IV Road, Pathumwan, Bangkok 10330, Thailand.
  • Supakij Khomvilai
    Surgical Endoscopy Colorectal Division, Department of Surgery, Faculty of Medicine, Chulalongkorn University, 1873 Rama IV Road, Pathumwan, Bangkok 10330, Thailand.
  • Ayako Miyata
    Department of International Clinical Development, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
  • Taro Shibata
    Biostatistics Division, National Cancer Center, Tokyo, Japan.
  • Yutaka Saito
    National Cancer Center Hospital, Tokyo, Japan (Y.S.).

Keywords

External Resources

Popular Topics
Recent Journals