Early Stage Lung Cancer Screening With Low-dose Computed Tomographic

Study Overview
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Brief Summary
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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.

Official Title
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Community-based Early Stage Lung Cancer Screening With Low-dose Computed Tomography in China

Conditions
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Lung Cancer

Intervention / Treatment
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* Device: Low Dose Computed Tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible participants were those aged 45-70 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: 70 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Screening Arm<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 4 mm.<br>|
| No Intervention: Passive Arm<br>Eligible subjects were randomized to follow up in usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung cancer screening, low-dose CT, high-risk population