China Lung Cancer Screening (CLUS) Study Version 2.0

Study Overview
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Brief Summary
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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.

Official Title
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Community-based Lung Cancer Screening With Low-dose CT in China (CLUS Study) Version 2.0

Conditions
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Lung Neoplasms

Intervention / Treatment
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* Device: Low Dose Computed Tomography
* Device: artificial intelligence (AI)
* Diagnostic Test: autofluorescence imaging (AFI)


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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: LDCT Screening<br>LDCT was performed at baseline + 2 biennial repeated LDCT rounds | Device: Low Dose Computed Tomography<br>* LDCT were performed in screening arm. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 5 mm<br>Device: artificial intelligence (AI)<br>* AI was performed in high-risk individuals recruitment and lung nodules management<br>Diagnostic Test: autofluorescence imaging (AFI)<br>* AFI applied in screening of centrally located SCC.<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 AI in enhancing the attendance rate of high-risk individuals | 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 | 5 year | 

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 year | 
| The incidence rate lung cancer | Assess the number of lung cancer incidences after each round of screening | 5 years |