Results of the Cancer Screening Feasibility Study in China: A Multicentered Randomized Controlled Trial of Lung and Colorectal Cancer Screening

Abstract

Abstract Objective To provide an understanding of important aspects of the participant recruitment and data collection, become aware of any potential problems, and obtain necessary information in order to design a large-scale randomized controlled trial (RCT) for lung and colorectal cancer screening in China. Methods This feasibility study was a multicentered, open label, pilot randomized trial. A total of 2696 participants who were at high risk of lung cancer were recruited from three screening centers and randomly allocated to arm 1 (n=894), annual low-dose computed tomography (LDCT) plus a baseline colonoscopy; arm 2 (n=902), biennial LDCT plus annual fecal immunochemical test (FIT) with OC-Sensor (OC-FIT); arm 3 (n=900), annual Insure-FIT plus Septin 9 blood test. Information on randomization, compliance, positivity rate, cancer case detection, and contamination with screening for lung cancer and colorectal cancer were collected. Results Participant characteristics were similar across study arms. The compliance rate of annual LDCT screening in arm 1 was 86.4% (95% CI: 83.9%, 88.5%) at baseline (T0), and 69.0% (95% CI: 65.8%, 72.0%) and 70.7% (95% CI: 67.6%, 73.7%) at the following two rounds (T1 and T2). The compliance rates of biennial LDCT screening in arm 2 were similar to those in arm 1 in the corresponding rounds. The compliance rate was 55.5% (95% CI: 52.2%, 58.8%) for colonoscopy in arm 1, while the compliance rates of OC-FIT, Insure-FIT and the Septin 9 test in arms 2 and 3 were all approximately 90% at T0, decreasing to 65%-80% at T1 and T2. The positivity rate, cancer case detection rate and contamination rate of screening for lung and colorectal cancer were also reported. Conclusion In this pilot study, the feasibility of an RCT in China of lung and colorectal cancer screening was demonstrated.