Comparative Evaluation of Participation and Diagnostic Yield of Colonoscopy vs Fecal Immunochemical Test vs Risk-Adapted Screening in Colorectal Cancer Screening: Interim Analysis of a Multicenter Randomized Controlled Trial (TARGET-C)

Abstract

INTRODUCTION: In colorectal cancer screening, implementing risk-adapted screening might be more effective than traditional screening strategies. We aimed to compare the effectiveness of a risk-adapted screening strategy with colonoscopy and fecal immunochemical test (FIT) in colorectal cancer screening. METHODS: A randomized controlled trial was conducted in 6 centers in China since May 2018. Nineteen thousand five hundred forty-six eligible participants aged 50–74 years were recruited and randomly allocated into 1 of the 3 screening groups in a 1:2:2 ratio: (i) one-time colonoscopy (n = 3,916), (ii) annual FIT (n = 7,854), and (iii) annual risk-adapted screening (n = 7,776). Based on the risk-stratification score, high-risk subjects were referred for colonoscopy and low-risk ones were referred for FIT. All subjects with positive FIT were referred for diagnostic colonoscopy. The detection rate of advanced neoplasm was the primary outcome. The study is registered with the China Clinical Trial Registry (www.chictr.org.cn Identifier: ChiCTR1800015506). RESULTS: For baseline screening, the participation rates of the colonoscopy, FIT, and risk-adapted screening groups were 42.5% (1,665/3,916), 94.0% (7,386/7,854), and 85.2% (6,628/7,776), respectively. For the intention-to-screen analysis, the detection rates of advanced neoplasm were 2.40% (94/3,916), 1.13% (89/7,854), and 1.66% (129/7,776), with odds ratios (95% confidence intervals) 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 a colonoscopic 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. DISCUSSION: For baseline screening, the risk-adapted screening approach showed a high participation rate, and its diagnostic yield was superior to that of FIT at a similarly low load of colonoscopy.

Clinical characteristics, medical service utilization, and expenditure for colorectal cancer in China, 2005 to 2014: Overall design and results from a multicenter retrospective epidemiologic survey

“…The guaiac-based FOBT has largely been replaced worldwide by iFOBT/FIT, and a similar trend is also apparent in China. [23][24][25] Although comparable national data are not yet available, the reported FOBT participation rate (more specifically, FIT) was as high as 94.0% (range not reported), and the colonoscopy screening rate was 42.5% in an ongoing, randomized controlled trial that started in 5 provinces in China in 2018 26 ; some other reports from city-level or county-level population CRC screening programs have also reported participation rates of FOBT ranging from 30.1% to 97.7%. [23][24][25]27,28 An integrated, systematic review suggests that CRC would be 1 of the most cost-effective target cancers and could be given priority in future scaled-up screening programs for general populations in China.…”

Head-to-head comparison of the test performance of self-administered qualitative vs. laboratory-based quantitative fecal immunochemical tests in detecting colorectal neoplasm

“…The analysis was conducted based on the strategies for colorectal cancer screening in China (TARGET-C) study which is a multicentered randomized controlled trial to compare the effectiveness of one-time colonoscopy, annual FIT, and annual risk-adapted screening strategy in CRC screening. [ 14 , 15 ] A total of 19,582 participants, aged 50 to 74 years from six centers in China, were enrolled in the TARGET-C trial at baseline from May 2018 to June 2019. Detailed inclusion and exclusion criteria have been described in our previous publication.…”

“…Detailed inclusion and exclusion criteria have been described in our previous publication. [ 14 ] With signed informed consent, information including sociodemographic characteristics, history of bowel disease, clinical treatment, family history of cancer, disease history, and living habits was collected via a standardized epidemiological questionnaire. Colonoscopy appointments were scheduled for those who were assigned to the colonoscopy group, assessed at high-risk of CRC by the Asia-Pacific Colorectal Screening score, or had positive FIT results.…”

Implications of Lifestyle Factors and Polygenic Risk Score for Absolute Risk Prediction of Colorectal Neoplasm and Risk-Adapted Screening

“…The study was conducted in the context of the TARGET-C trial, an ongoing study comparing the effectiveness of colonoscopy, FIT, and risk-adapted screening in CRC conducted in six centers of China since May 2018. Detailed study design has been described in previous publications (Chen et al, 2019;Chen et al, 2020). Briefly, 19,582 eligible participants aged 50-74 years were randomized into three arms in a 1:2:2 ratio: 1) one-time colonoscopy; 2) annual FIT; and 3) annual risk-adapted screening.…”