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Effectiveness of Colonoscopy vs Fecal Immunochemical Test vs Risk-Adapted Screening in Colorectal Cancer Screening (TARGET-C): A Multi-Centre Randomised Controlled Trial
111 Pages Posted: 25 Oct 2019
More...Abstract
Background & Aims: In colorectal cancer (CRC) screening, utilizing risk prediction models to stratify populations and implementing risk-adapted screening might be more effective than traditional screening strategies. We aimed to compare the effectiveness of colonoscopy, fecal immunochemical test (FIT), and a risk-adapted screening strategy in CRC screening.
Methods: A randomised controlled trial was conducted in 6 study centres of 5 provinces in China since May, 2018. 19,546 eligible participants aged 50-74 years were recruited and randomly allocated into one of the 3 screening groups in a 1:2:2 ratio: 1) one-time colonoscopy (n=3916); 2) annual FIT (n=7854); 3) annual risk-adapted screening (n=7776). Based on the risk-stratification score, high-risk subjects were referred for colonoscopy, and low-risk ones were referred for FIT. The detection rate of advanced neoplasm (CRC and advanced adenoma) was the primary outcome. Interim analysis of the baseline screening was performed.
Findings: The overall participation rates of the colonoscopy, FIT, and risk-adapted screening groups were 42·5% (1665/3916), 94·0% (7386/7854), and 85·2% (6628/7776), respectively. For the intention-to-screen analysis, the detection rates for advanced neoplasm were 2·40% (94/3916), 1·13% (89/7854) and 1·66% (129/7776), with ORs (95% CIs) of 2·16 (1·61- 2·90; P<0.001) for colonoscopy vs. FIT, 1·45 (1·10-1·90; P <0.001) for colonoscopy vs. risk-adapted screening, and 1·49 (1·13-1·97; P <0.001) for risk-adapted screening vs. FIT, respectively. The numbers of subjects who required colonoscopy examination to detect 1 advanced neoplasm were 18 in the colonoscopy group, 10 in the FIT group, and 11 in the risk-adapted screening group.
Interpretation: For baseline screening, the risk-adapted screening approach showed a remarkably high participation rate, and its diagnostic yield was superior to the FIT group but inferior to the colonoscopy group.
Trial Registration: www.chictr.org.cn Identifier: ChiCTR1800015506.
Funding Statement: CAMS Innovation Fund for Medical Sciences (2017-I2M-1-006); National Natural Science Foundation of China (81703309); National Key Research and Development Plan Program (2016YFC1302702).
Declaration of Interests: The authors declare no competing interests.
Ethics Approval Statement: The study was approved by the respective institutional ethics committees of the participating centres. All participants provided written informed consent.
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