Our previous study, china lung cancer screening study version 1.0, had proven that LDCT led to a 74.1% increase in detecting early-stage lung cancer compare to usual care (NCT02898441). The present one arm study is performed to evaluate the efficacy of new techniques in improving the implementation of lung cancer screening and validate our previous findings. 6000 high-risk subjects (age 45-75) were recruited to take LDCT screening. (Baseline + 2 biennial repeated LDCT screening). Follow-up for lung cancer incidence, lung cancer mortality and overall mortality was performed. Blood samples were stored in a Biobank. Management of positive screening test was carried out by a pre-specified protocol.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
6,000
LDCT were performed in screening arm. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 5 mm
AI was performed in high-risk individuals recruitment and lung nodules management
AFI applied in screening of centrally located SCC.
Shanghai Chest hospital
Shanghai, Shanghai Municipality, China
RECRUITINGThe mortality rate of lung cancer
Assess lung cancer mortality within next 5 years after first round of screening
Time frame: 5 years
The attendance rate of high-risk individuals
Evaluate the ability of AI in enhancing the attendance rate of high-risk individuals
Time frame: 5 year
Diagnostic accuracy rate of lung cancer
Evaluate the ability of AI, AFI and molecular biomarkers in enhancing the diagnostic accuracy rate of lung cancer
Time frame: 5 year
The mortality of all-cause
Assess all-cause mortality within next 5 years after first round of screening
Time frame: 5 years
The detection rate of lung nodules
Assess lung nodules detection rate, and the types and sizes of nodules detected in LDCT screening
Time frame: 5 year
The incidence rate lung cancer
Assess the number of lung cancer incidences after each round of screening
Time frame: 5 years
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