Hongda Chen1, Ming Lu1, Chengcheng Liu1, Shuangmei Zou2, Lingbin Du3, Xianzhen Liao4, Dong Dong5, Donghua Wei6, Yi Gao7, Chen Zhu3, Liming Zhu8, Weifang Zheng9, Haifan Xiao4, Yunxin Kong5, Huiping Yin6, Hai Zhou10, Rongbiao Ying11, Baoquan Wang12, Juan Zhang6, Xiaopeng Zhang13, Qiang Zhang14, Xuan Zhang7, Yuhan Zhang1, Hong Wang1, Lanwei Guo1,15, Li Liu16, Jiansong Ren1, Jufang Shi1, Ni Li1, Xiaoping Miao16, Hermann Brenner17,18,19, Min Dai1. 1. Office of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. 2. Department of Pathology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. 3. Department of Cancer Prevention, Institute of Cancer and Basic Medicine (ICBM), Chinese Academy of Sciences/Cancer Hospital of University of Chinese Academy of Sciences/Zhejiang Cancer Hospital. 4. Department of Cancer Prevention, Hunan Cancer Hospital, Changsha, China. 5. Office of Cancer Prevention and Treatment, Xuzhou Cancer Hospital, Xuzhou, China. 6. Department of Cancer Prevention, Anhui Provincial Cancer Hospital, Hefei, China. 7. Department of Colorectal Surgery, Tumor Hospital of Yunnan Province/Third Affiliated Hospital of Kunming Medical University, Kunming, China. 8. Department of Medical Oncology, Institute of Cancer and Basic Medicine (ICBM), Chinese Academy of Sciences/Cancer Hospital of University of Chinese Academy of Sciences/Zhejiang Cancer Hospital. 9. Department of Proctology, Lanxi Red Cross Hospital, Jinhua, China. 10. Administrative Management Office of Yunan Cancer Center, Yunnan Cancer Hospital/The Third Affiliated Hospital of Kunming Medical University/Yunnan Cancer Center, Kunming, China. 11. Department of Surgical Oncology, Taizhou Cancer Hospital, Taizhou, China. 12. Department of Public Health, Lanxi Red Cross Hospital, Jinhua, China. 13. Department of NCD Prevention and Heath Education, Hefei Center for Disease Control and Prevention, Hefei, China. 14. Department of Cancer Prevention, Tumor Hospital of Yunnan Province/Third Affiliated Hospital of Kunming Medical University, Kunming, China. 15. Henan Office for Cancer Control and Research, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China. 16. Department of Epidemiology and Biostatistics, and the Ministry of Education Key Lab of Environment and Health, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. 17. Division of Clinical Epidemiology and Aging Research, German Cancer Research Center (DKFZ), Heidelberg, Germany. 18. Division of Preventive Oncology, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT), Heidelberg, Germany. 19. German Cancer Consortium (DKTK), German Cancer Research Center (DKFZ), Heidelberg, Germany.
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.
RCT Entities:
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.
Authors: U Strömberg; C Bonander; M Westerberg; L Å Levin; C Metcalfe; R Steele; L Holmberg; A Forsberg; R Hultcrantz Journal: EClinicalMedicine Date: 2022-04-16
Authors: Hongda Chen; Li Liu; Ming Lu; Yuhan Zhang; Bin Lu; Ying Zhu; Jianbo Tian; Xinying Li; Shaofa Nie; Xiaoping Miao; Min Dai Journal: Front Mol Biosci Date: 2021-07-16