A Randomized Controlled Trial Evaluating the Effectiveness of a Novel Risk-Stratified Screening Strategy for Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60,000
- 主要终点
- Positive Predictive Value (PPV) of Screening Strategies
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Residents with local household registration residing continuously in the region for ≥3 years.
- •Aged 40-74 years at enrollment.
排除标准
- •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.
研究组 & 干预措施
Prediction Model Arm
Lung Cancer Risk Prediction Model Arm
干预措施: Prediction Model Arm (Diagnostic Test)
Standard Screening Arm
Traditional High-Risk Factors Arm
干预措施: Standard Screening Arm (Diagnostic Test)
结局指标
主要结局
Positive Predictive Value (PPV) of Screening Strategies
时间窗: 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.
次要结局
- 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)
研究者
Jianxing He
Principal Investigator
The First Affiliated Hospital of Guangzhou Medical University