A Randomized Controlled Trial Evaluating the Effectiveness of a Novel Risk-Stratified Screening Strategy for Lung Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60,000
- Primary Endpoint
- Positive Predictive Value (PPV) of Screening Strategies
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 74 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Residents with local household registration residing continuously in the region for ≥3 years.
- •Aged 40-74 years at enrollment.
Exclusion Criteria
- •Prior diagnosis of lung cancer (histologically/cytologically confirmed)
- •Currently receiving active treatment for any malignancy.
- •Presence of severe comorbidities with life expectancy <5 years
- •Participation in any lung cancer screening program within 5 years.
- •Functional dependency (ADL score ≤2) OR unwillingness to comply with protocol-required follow-up.
- •Declined to provide written informed consent.
Arms & Interventions
Prediction Model Arm
Lung Cancer Risk Prediction Model Arm
Intervention: Prediction Model Arm (Diagnostic Test)
Standard Screening Arm
Traditional High-Risk Factors Arm
Intervention: Standard Screening Arm (Diagnostic Test)
Outcomes
Primary Outcomes
Positive Predictive Value (PPV) of Screening Strategies
Time Frame: 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 Outcomes
- Sensitivity of Screening Strategies(From screening to 12-month follow-up)
- Specificity of Screening Strategies(From screening to 12-month follow-up)
- Negative Predictive Value (NPV)(From screening to 12-month follow-up)
- Early-Stage Shift Proportion(At time of cancer diagnosis (within 3 months post-positive screening))
- Lung Cancer-Specific Mortality Rate(From randomization to 3-year follow-up)
- Overall Survival in Screen-Detected Lung Cancer(From cancer diagnosis to 3-year follow-up)
Investigators
Jianxing He
Principal Investigator
The First Affiliated Hospital of Guangzhou Medical University