Background:To provide an understanding of important aspects of the participant recruitment and data collec-tion,become aware of any potential problems,and obtain necessary information in order to design a large-scale ...Background:To provide an understanding of important aspects of the participant recruitment and data collec-tion,become aware of any potential problems,and obtain necessary information in order to design a large-scale randomized controlled trial(RCT)for lung cancer and colorectal cancer(CRC)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);and 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 CRC 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 cancer and CRC were also reported.Conclusion:In this pilot study,the feasibility of an RCT in China of lung cancer and CRC screening was demon-strated.展开更多
文摘Background:To provide an understanding of important aspects of the participant recruitment and data collec-tion,become aware of any potential problems,and obtain necessary information in order to design a large-scale randomized controlled trial(RCT)for lung cancer and colorectal cancer(CRC)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);and 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 CRC 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 cancer and CRC were also reported.Conclusion:In this pilot study,the feasibility of an RCT in China of lung cancer and CRC screening was demon-strated.
