The investigators propose a randomized controlled trial to evaluate the clinical effectiveness of low-dose computed tomography (LDCT) for lung cancer screening in high-risk Chinese ever-smokers aged 50-79 years in Hong Kong and to assess the cost-effectiveness of implementing LDCT for lung cancer screening in the local setting.
Adults aged between 50 and 79 years
Current smokers or ex-smokers quitted for less than 10 years, with a history of cigarette smoking equivalent to at least 20 pack-years
Non-Chinese population
Individuals who are not mentally competent to provide informed consent (e.g., those with a history of dementia)
Individuals with a known prior diagnosis of lung cancer or detection of lung nodules
Individuals with a history of other cancers within the last five years or currently under treatment
Parallel
Low-dose computed tomography (LDCT)
Diagnostic test3 rounds of LDCT screening performed at the baseline (T0), 18 ± 3 months (T1), 42 ± 3 months (T2) from baseline
Lung cancer mortality
Defined as the lung cancer-related death. The survival status of diagnosed lung cancer patients in both arms will be reviewed yearly after the first five years up to 10 years through Hospital Authority of Hong Kong (HA)'s Data Sharing Portal services or the Deaths Registry, supplemented by access to Clinical Management System (CMS) if needed. The lung cancer mortality rate will be calculated by dividing (a) the number of lung cancer-related deaths by (b) the number of person-years.
Stage distribution of lung cancer cases
Defined as the stage distribution of lung cancer cases in both arms. The number of lung cancer cases of diagnosed cancer stages, namely, stages 1, 2, 3, and 4, as well as unstaged, will be recorded.
Lung cancer incidence
Long-term lung cancer-related data will be extracted through electronic medical record systems to evaluate the changes in lung cancer incidence rate in both arms. Data on lung cancer incidence related details and the survival status will be reviewed yearly up to 10 years through the Hospital Authority of Hong Kong (HA)'s Data Sharing Portal and the Deaths Registry, and to be supplemented by access to Clinical Management System (CMS) at HA for clarification and checking of specific issues if needed.
Prevalence of false-positive of screening cases
A false positive screen refers to a positive screen that no lung cancer is diagnosed after undergoing further confirmatory diagnostic workup. The prevalence of false-positive of screening cases is calculated as dividing (a) the number of false positive screenings by (b) the total number of scans performed.
Percentage of overdiagnosis of lung cancer cases
Overdiagnosis refers to a screen-detected lung cancer case that would not be diagnosed if screening is not performed. The overdiagnosis percentage in all diagnosed lung cancer cases in the screening arm is calculated as dividing (a) the difference between the rate of lung cancer detected in the screening arm and the control arm by (b) the rate of lung cancer detected in the screening arm.
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The University of Hong Kong
Lead sponsor
The Hong Kong Jockey Club Charities Trust
Collaborator
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