Lung Cancer Screening
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTStandard Screening Arm
Participants are screened based on NCCN guideline criteria. High-risk individuals receive LDCT screening. Thoracic physicians guide management of screen-positive cases.
DIAGNOSTIC_TESTPrediction Model Arm
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.
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 74 Years
Healthy volunteers
Yes
Inclusion criteria
1. Residents with local household registration residing continuously in the region for ≥3 years. 2. Aged 40-74 years at enrollment.
Exclusion criteria
1. Prior diagnosis of lung cancer (histologically/cytologically confirmed) 2. Currently receiving active treatment for any malignancy. 3. Presence of severe comorbidities with life expectancy \<5 years 4. Participation in any lung cancer screening program within 5 years. 5. Functional dependency (ADL score ≤2) OR unwillingness to comply with protocol-required follow-up. 6. Declined to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive Predictive Value (PPV) of Screening Strategies | From enrollment through completion of diagnostic confirmation (up to 3 months post-screening) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Specificity of Screening Strategies | From screening to 12-month follow-up | 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 |
| Negative Predictive Value (NPV) | From screening to 12-month follow-up | 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. |
| Sensitivity of Screening Strategies | From screening to 12-month follow-up | 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 |
| Lung Cancer-Specific Mortality Rate | From randomization to 3-year follow-up | 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. |
| Overall Survival in Screen-Detected Lung Cancer | From cancer diagnosis to 3-year follow-up | 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. |
| Early-Stage Shift Proportion | At time of cancer diagnosis (within 3 months post-positive screening) | 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%. |
Contacts
Primary ContactWenhua Liang professor, doctor
Backup ContactHuiting Wang
Outcome results
None listed