Korean colonoscopy screening pilot study (K-cospi) for screening colorectal cancer: study protocol for the multicenter, community-based clinical trial

Abstract

Background: The Korean National Cancer Screening Program has been providing annual fecal immunochemical test for colorectal cancer (CRC) to adults aged 50 years and older since 2004. The Korean Colonoscopy Screening Pilot Study was developed to evaluate the efectiveness of colonoscopy screening for CRC incidence and mortality, screening-related complications, and acceptability of colonoscopy as a primary modality for the national CRC screening program.

Methods: This study and its protocols have been approved by the Korean Public Institutional Review Board and the National Cancer Center Institutional Review Board. We obtain written informed consent from all participants. The target population is males and females aged 50?74 years living within the pilot sites. A total of 26,640 participants will be recruited for colonoscopy screening. Subjects who have been diagnosed with CRC, who are currently undergoing treatment for CRC, or who have undergone colonoscopy screening within the past 5 years are not allowed to participate. All participants need to complete baseline questionnaires. This pilot study is currently conducted by 104

endoscopists from 57 national cancer screening institutions (42 primary, 10 secondary, and 5 tertiary institutions). Participating endoscopists at each medical institution perform colonoscopy and report the colonoscopy results to a centralized electronic case report system. We conduct a telephone survey after 7 days and 4 weeks post-colonoscopy to assess for procedure-related complications and satisfaction of the participants. In case of abnormal fndings from colonoscopy screening, we track the results from follow-up diagnostic tests. Data from this pilot study will be linked to the diagnostic workup results, the Korean Cancer Registry, and death certifcate data for analysis of the performance, long-term efects, and cost-efectiveness of colonoscopy.