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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

See all articles by Hongda Chen

Hongda Chen

National Cancer Centre - Office of Cancer Screening

Ming Lu

National Cancer Centre - Office of Cancer Screening

Chengcheng Liu

National Cancer Centre - Office of Cancer Screening

Shuangmei Zou

National Cancer Centre

Lingbin Du

Chinese Academy of Sciences (CAS) - Institute of Cancer and Basic Medicine (ICBM)

Xianzhen Liao

Central South University - Hunan Cancer Hospital

Dong Dong

Xuzhou Cancer Hospital

Donghua Wei

Anhui Provincial Cancer Hospital

Yi Gao

Kunming Medical University - Third Affifiliated Hospital

Chen Zhu

Chinese Academy of Sciences (CAS)

Liming Zhu

Chinese Academy of Sciences (CAS) - Cancer Hospital

Weifang Zheng

Lanxi Red Cross Hospital

Haifan Xiao

Central South University - Hunan Cancer Hospital

Yunxin Kong

Xuzhou Cancer Hospital

Huiping Yin

Anhui Provincial Cancer Hospital

Hai Zhou

Kunming Medical University - Third Affifiliated Hospital

Rongbiao Ying

Taizhou Cancer Hospital

Baoquan Wang

Lanxi Red Cross Hospital

Juan Zhang

Anhui Provincial Cancer Hospital

Xiaopeng Zhang

Hefei Centre for Disease Control and Prevention

Qiang Zhang

Kunming Medical University - Third Affifiliated Hospital

Xuan Zhang

Kunming Medical University - Third Affifiliated Hospital

Yuhan Zhang

National Cancer Centre - Office of Cancer Screening

Hong Wang

National Cancer Centre - Office of Cancer Screening

Li Liu

Huazhong University of Science and Technology - Department of Epidemiology and Biostatistics

Jiansong Ren

National Cancer Centre - Office of Cancer Screening

Jufang Shi

Chinese Academy of Medical Sciences & Peking Union Medical College (CAMS & PUMC) - Office of Cancer Screening

Ni Li

Chinese Academy of Medical Sciences & Peking Union Medical College (CAMS & PUMC) - Office of Cancer Screening

Xiaoping Miao

Huazhong University of Science and Technology - Department of Epidemiology and Biostatistics

Min Dai

National Cancer Centre - Office of Cancer Screening

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.

Suggested Citation

Chen, Hongda and Lu, Ming and Liu, Chengcheng and Zou, Shuangmei and Du, Lingbin and Liao, Xianzhen and Dong, Dong and Wei, Donghua and Gao, Yi and Zhu, Chen and Zhu, Liming and Zheng, Weifang and Xiao, Haifan and Kong, Yunxin and Yin, Huiping and Zhou, Hai and Ying, Rongbiao and Wang, Baoquan and Zhang, Juan and Zhang, Xiaopeng and Zhang, Qiang and Zhang, Xuan and Zhang, Yuhan and Wang, Hong and Liu, Li and Ren, Jiansong and Shi, Jufang and Li, Ni and Miao, Xiaoping and Dai, Min, Effectiveness of Colonoscopy vs Fecal Immunochemical Test vs Risk-Adapted Screening in Colorectal Cancer Screening (TARGET-C): A Multi-Centre Randomised Controlled Trial (October 18, 2019). Available at SSRN: https://ssrn.com/abstract=3472004 or http://dx.doi.org/10.2139/ssrn.3472004

Hongda Chen

National Cancer Centre - Office of Cancer Screening

Beijing
China

Ming Lu

National Cancer Centre - Office of Cancer Screening

Beijing
China

Chengcheng Liu

National Cancer Centre - Office of Cancer Screening

Beijing
China

Shuangmei Zou

National Cancer Centre

Beijing
China

Lingbin Du

Chinese Academy of Sciences (CAS) - Institute of Cancer and Basic Medicine (ICBM)

Hangzhou, 310022
China

Xianzhen Liao

Central South University - Hunan Cancer Hospital

Changsha, 410013
China

Dong Dong

Xuzhou Cancer Hospital

Xuzhou
China

Donghua Wei

Anhui Provincial Cancer Hospital

Hefei
China

Yi Gao

Kunming Medical University - Third Affifiliated Hospital

Kunming
China

Chen Zhu

Chinese Academy of Sciences (CAS)

52 Sanlihe Rd.
Datun Road, Anwai
Beijing, Xicheng District 100864
China

Liming Zhu

Chinese Academy of Sciences (CAS) - Cancer Hospital

Hangzhou, 310022
China

Weifang Zheng

Lanxi Red Cross Hospital

Jinhua
China

Haifan Xiao

Central South University - Hunan Cancer Hospital

Changsha, 410013
China

Yunxin Kong

Xuzhou Cancer Hospital

Xuzhou
China

Huiping Yin

Anhui Provincial Cancer Hospital

Hefei
China

Hai Zhou

Kunming Medical University - Third Affifiliated Hospital

Kunming
China

Rongbiao Ying

Taizhou Cancer Hospital

Taizhou
China

Baoquan Wang

Lanxi Red Cross Hospital

Jinhua
China

Juan Zhang

Anhui Provincial Cancer Hospital

Hefei
China

Xiaopeng Zhang

Hefei Centre for Disease Control and Prevention

Hefei
China

Qiang Zhang

Kunming Medical University - Third Affifiliated Hospital

Kunming
China

Xuan Zhang

Kunming Medical University - Third Affifiliated Hospital

Kunming
China

Yuhan Zhang

National Cancer Centre - Office of Cancer Screening

Beijing
China

Hong Wang

National Cancer Centre - Office of Cancer Screening

Beijing
China

Li Liu

Huazhong University of Science and Technology - Department of Epidemiology and Biostatistics

China

Jiansong Ren

National Cancer Centre - Office of Cancer Screening

Beijing
China

Jufang Shi

Chinese Academy of Medical Sciences & Peking Union Medical College (CAMS & PUMC) - Office of Cancer Screening

Beijing
China

Ni Li

Chinese Academy of Medical Sciences & Peking Union Medical College (CAMS & PUMC) - Office of Cancer Screening

Beijing
China

Xiaoping Miao

Huazhong University of Science and Technology - Department of Epidemiology and Biostatistics ( email )

China

Min Dai (Contact Author)

National Cancer Centre - Office of Cancer Screening ( email )

Beijing
China