The present study is a randomized controlled trial of LDCT screening for lung cancer versus usual care. 6000 high-risk subjects (age 45-70) were recruited and randomized to the Active arm (Baseline + 2 biennial repeated LDCT screening) or to the Passive arm, followed up in usual care (Baseline + 2 biennial repeated questionnaire inquiries). Follow-up for lung cancer incidence, lung cancer mortality and overall mortality was performed. Blood samples were stored from the Active arm in a Biobank. Management of positive screening test was carried out by a pre-specified protocol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
6,000
LDCT were performed in screening arm. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 4 mm.
Shanghai Chest hospital
Shanghai, Shanghai Municipality, China
RECRUITINGLung cancer incidence rate
Assess the number of lung cancer incidences after each round of screening in both arms. Compared the stage differences between screening arm and usual care arm.
Time frame: 5 years
Lung cancer mortality
Assess lung cancer mortality in both arms within next 5 years after first round of screening.
Time frame: 5 years
All-cause mortality
Assess all-cause mortality in both arms within next 5 years after first round of screening.
Time frame: 5 years
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