NCT05494021 China Lung Cancer Screening (CLUS) Study Version 3.0
| NCT ID | NCT05494021 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Chest Hospital |
| Condition | Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100,000 participants |
| Start Date | 2022-01-01 |
| Primary Completion | 2026-12-31 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Eligible participants were those aged 45-75 years, and with either of the following risk factors: 1. history of cigarette smoking ≥ 20 pack-years, and, if former smokers, had quit within the previous 15 years; 2. malignant tumors history in immediate family members; 3. personal cancer history; 4. professional exposure to carcinogens; 5. long term exposure to second-hand smoke; 6. 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
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