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A nationwide population-based multi-center RCT enrolling ≥60,000 eligible residents to compare screening effectiveness between risk-prediction-model-driven and traditional guideline-based high-risk lung cancer screening strategies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prediction Model Arm | Experimental | Lung Cancer Risk Prediction Model Arm |
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| Standard Screening Arm | Active Comparator | Traditional High-Risk Factors Arm |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prediction Model Arm | Diagnostic Test | Lung cancer risk stratification via prediction model integrating: advanced age, lung cancer family history, personal cancer history, childhood coal exposure, asthma history, and food allergy history. High-risk individuals receive LDCT screening. Thoracic physicians guide management of screen-positive cases. |
| Measure | Description | Time Frame |
|---|---|---|
| Positive Predictive Value (PPV) of Screening Strategies | Proportion of true lung cancer cases among participants with positive screening results, confirmed by histopathology within 3 months after screening. Calculated as: (True Positives) / (True Positives + False Positives) × 100%. Assessed separately for both screening arms. | From enrollment through completion of diagnostic confirmation (up to 3 months post-screening) |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of Screening Strategies | Proportion of true lung cancer cases correctly identified by screening, confirmed through histopathology within 6 months. Calculated as: True Positives / (True Positives + False Negatives) × 100%. Includes interval cancers detected within 12 months post-screening | From screening to 12-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenhua Liang professor, doctor | Contact | +86 020-83062808 | liangwh1987@163.com | |
| Huiting Wang | Contact | +86 15622132598 | wangh1805657064@163.com |
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| Standard Screening Arm | Diagnostic Test | Participants are screened based on NCCN guideline criteria. High-risk individuals receive LDCT screening. Thoracic physicians guide management of screen-positive cases. |
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| Specificity of Screening Strategies |
Proportion of cancer-free participants correctly identified as screening-negative. Calculated as: True Negatives / (True Negatives + False Positives) × 100%. Cancer-free status confirmed by 12-month follow-up |
| From screening to 12-month follow-up |
| Negative Predictive Value (NPV) | Proportion of screening-negative participants without lung cancer. Calculated as: True Negatives / (True Negatives + False Negatives) × 100%. Absence of cancer confirmed by 12-month follow-up including LDCT and clinical evaluation. | From screening to 12-month follow-up |
| Early-Stage Shift Proportion | Percentage of screen-detected lung cancer cases diagnosed at early stage (AJCC 8th ed. Stage I-II) versus late stage (Stage III-IV). Calculated as: (Early-stage cases) / (Total screen-detected cases) × 100%. | At time of cancer diagnosis (within 3 months post-positive screening) |
| Lung Cancer-Specific Mortality Rate | Death rate attributable to lung cancer, verified by independent mortality review committee using ICD-10 codes (C34.0-C34.9) and medical records. Expressed as deaths per 1,000 person-years. | From randomization to 3-year follow-up |
| Overall Survival in Screen-Detected Lung Cancer | Time from pathological diagnosis of lung cancer to death from any cause. Assessed using Kaplan-Meier method with censoring at last follow-up. Reported as median survival with 95% CI. | From cancer diagnosis to 3-year follow-up |