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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole-process management strategy | Experimental | 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. |
|
| Rountine screening strategy | Active Comparator | LDCT was performed at baseline + 2 biennial repeated LDCT rounds. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole-process management software | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Eligible participants were those aged 45-75 years, and with either of the following risk factors:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest hospital | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| LDCT detection | Device | LDCT were performed in both arm. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 5 mm |
|
| 5 years |
| The incidence rate lung cancer | Assess the number of lung cancer incidences after each round of screening | 5 years |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |