China Lung Cancer Screening (CLUS) Study Version 3.0

Study Overview
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Brief Summary
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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.

Official Title
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Lung Cancer Screening With Low-dose CT in China (CLUS Study) Version 3.0

Conditions
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Lung Cancer

Intervention / Treatment
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* Other: Whole-process management software
* Device: LDCT detection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible participants were those aged 45-75 years, and with either of the following risk factors: history of cigarette smoking ≥ 20 pack-years, and, if former smokers, had quit within the previous 15 years; malignant tumors history in immediate family members; personal cancer history; professional exposure to carcinogens; long term exposure to second-hand smoke; long term exposure to cooking oil fumes. Exclusion Criteria: Had a CT scan of chest within last 12 months History of any cancer within 5 years

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whole-process management strategy<br>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<br>* 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.<br>Device: LDCT detection<br>* LDCT were performed in both arm. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 5 mm<br>|
| Active Comparator: Rountine screening strategy<br>LDCT was performed at baseline + 2 biennial repeated LDCT rounds. | Device: LDCT detection<br>* LDCT were performed in both arm. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 5 mm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mortality rate of lung cancer | Assess lung cancer mortality within next 5 years after first round of screening | 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 | 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 | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mortality of all-cause | Assess all-cause mortality within next 5 years after first round of screening | 5 years | 
| The detection rate of lung nodules | Assess lung nodules detection rate, and the types and sizes of nodules detected in LDCT screening | 5 years | 
| The incidence rate lung cancer | Assess the number of lung cancer incidences after each round of screening | 5 years |