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The present study is a randomized controlled trial of LDCT screening for lung cancer versus usual care. 6000 high-risk subjects (age 45-70) were recruited and randomized to the Active arm (Baseline + 2 biennial repeated LDCT screening) or to the Passive arm, followed up in usual care (Baseline + 2 biennial repeated questionnaire inquiries). Follow-up for lung cancer incidence, lung cancer mortality and overall mortality was performed. Blood samples were stored from the Active arm 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 |
|---|---|---|---|
| Screening Arm | Active Comparator | LDCT was performed at baseline + 2 biennial repeated LDCT rounds |
|
| Passive Arm | No Intervention | Eligible subjects were randomized to follow up in usual care |
| 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 4 mm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lung cancer incidence rate | Assess the number of lung cancer incidences after each round of screening in both arms. Compared the stage differences between screening arm and usual care arm. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Lung cancer mortality | Assess lung cancer mortality in both arms within next 5 years after first round of screening. | 5 years |
| All-cause mortality | Assess all-cause mortality in both arms within next 5 years after first round of screening. |
| Measure | Description | Time Frame |
|---|---|---|
| Nodule detection rate | Assess nodule detection rate, and the types and sizes of nodules detected in LDCT screening arm. | One year |
Inclusion Criteria:
Eligible participants were those aged 45-70 years, and with either of the following risk factors:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Baohui Han, MD, PhD | Contact | 86-21-62821990 | 3301 | xkyyhan@gmail.com |
| Yanwei Zhang, MD, PhD | Contact | 86-21-62821990 | 3306 | zhangyw198691@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Baohui Han, MD, PhD | Shanghai Chest Hospital | Principal Investigator |
| 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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| ID | Term |
|---|---|
| D014057 | Tomography, X-Ray Computed |
| ID | Term |
|---|---|
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 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 |