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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LDCT Screening | Other | LDCT was performed at baseline + 2 biennial repeated LDCT rounds |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Dose Computed Tomography | Device | LDCT were performed in screening arm. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 5 mm |
|
| 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 |
| 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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Baohui Han, MD Dr. | Contact | 8618930858216 | 18930858216@163.com | |
| Yanwei Zhang, MD Dr. | Contact | 8618930599895 | zhangyw198691@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest hospital | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36451312 | Derived | Zhang Y, Liu W, Zhang H, Sun B, Chen T, Hu M, Zhou H, Cao Y, Han B, Wu L. Extracellular vesicle long RNA markers of early-stage lung adenocarcinoma. Int J Cancer. 2023 Apr 1;152(7):1490-1500. doi: 10.1002/ijc.34386. Epub 2022 Dec 15. |
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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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| ID | Term |
|---|---|
| D014057 | Tomography, X-Ray Computed |
| D061848 | Optical Imaging |
| ID | Term |
|---|---|
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| artificial intelligence (AI) | Device | AI was performed in high-risk individuals recruitment and lung nodules management |
|
| autofluorescence imaging (AFI) | Diagnostic Test | AFI applied in screening of centrally located SCC. |
|
| 5 year |
| 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 |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D014054 | Tomography |
| D008919 | Investigative Techniques |