An interventional study of Whole-process management software and LDCT detection in Lung Cancer, sponsored by Shanghai Chest Hospital. Recruiting at 1 site in China. Open to participants aged 45 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-09.
Sponsored by Shanghai Chest Hospital · Not applicable, Interventional, and Screening
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.
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Eligible participants were those aged 45-75 years, and with either of the following risk factors:
Exclusion Criteria:
High-risk individuls are provided with whole-process management strategy, including 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 was performed at baseline + 2 biennial repeated LDCT rounds.
Other: Whole-process management software · Device: LDCT detection
LDCT was performed at baseline + 2 biennial repeated LDCT rounds.
Device: LDCT detection
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
The 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
Plan to share: No
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Shanghai Chest Hospital