The Feasibility Study Of The Randomized Cancer Screening Trial In China

HU P. ² , SHI J. ¹ , REN J. ¹ , LI J. ¹ , LI N. ¹ , PINSKY P. ² , PROROK P. ² , FAGERSTROM R. ² , TAYLOR M. ² , KRAMER B. ² , HE J. ¹

Purpose: Lung cancer has been the leading cause of cancer death in China. The US National Lung Screening Trial (NLST) showed a 15-20% mortality reduction in a high-risk population with annual Low-Dose Computed Tomography (LDCT). China hasn't yet developed national guidelines for lung and colorectal cancer screening and needs scientific evidence from the Chinese population for making policy. The aim of this study is to obtain information necessary to design a long-term randomized lung and colorectal cancer screening trial in China.
Methods: Individuals at elevated risk in three centers were randomized into three arms: ① annual LDCT and baseline colonoscopy; ② every other year LDCT plus annual fecal immunochemical test (FIT); ③ annual FIT plus Septin-9 test. The randomization was stratified on gender and 5 age groups (50-74). This study was approved by Ethics Committee of Cancer Hospital, Chinese Academy of Medical Science in June, 2014 and registered in Chinese Clinical Trial Registry.  
Results: From August, 2014 to March, 2015, 2696 eligible participants were recruited at baseline. The rate of adherence to screening was 90.0%. 1598 participants received LDCT. The abnormality rate was 77.4% with LDCT and suspicious rate for lung cancer were 6.5% and 6.1% for arm 1 and arm 2, respectively. 2150 participants received colorectal cancer screening. The positivity rate was 34.1% with colonoscopy screening, 9.7% with FIT, and 5.8% with Septin9 test.
Conclusions: This is the first randomized trial of lung and colorectal cancer screening in China. The feasibility study will help develop a practical design for the Large-scale Randomized Cancer Screening Trial in China.
Funding resource: International Cooperative Project by Ministry of Science and Technology, China