CLUS version 1.0, had proven that LDCT led to a 74.1% increase in detecting early-stage lung cancer compare to usual care (NCT02898441). CLUS version 2.0 evaluated the efficacy of new techniques (AI, AFI and MTB) in fostering the implementation of lung cancer screening (NCT03975504). The present multi-center study is performed to evaluate the effectiveness of different lung cancer screening strategy and validate our previous findings. 100,000 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
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
100,000
Enrolled participants will managed by a pre-designed software. The software would provide helpful assistance, such as lung cancer education, decision-making, assisting in making and attending LCS LDCT appointments, arranging follow-up when needed, tobacco cessation support for smokers, treatment assistance if diagnosed as lung cancer.
LDCT were performed in both arm. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 5 mm
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 whole-process management strategy in enhancing the attendance rate of high-risk individuals
Time frame: 5 years
The adherence rate of high-risk individuals
Evaluate the ability of whole-process management strategy in enhancing the adherence rate of high-risk individuals
Time frame: 5 years
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 years
The incidence rate lung cancer
Assess the number of lung cancer incidences after each round of screening
Time frame: 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.