Clinical Utility of Circulating Tumor DNA Methylation in the Diagnosis of Primary Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Diagnostic sensitivity of ctDNA methylation sequencing
研究概览
简要总结
This study aims to investigate the utility of circulating tumor DNA (ctDNA) methylation sequencing in the diagnosis of primary lung cancer.
详细描述
Plasma sample of patients with and without lung cancer will be collected and analyzed using methylation-sensitive enzyme sequencing method. Diagnostic performance of ctDNA methylation sequencing will be compared with that of tumor markers (CEA, Cyfra 21-1, and NSE) combined.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lung cancer group
- •Pathologically proven lung cancer
- •Clinically suspected lung cancer on chest CT scan
- •Benign pulmonary disease group
- •Chronic obstructive pulmonary disease, interstitial lung disease, pneumonia, bronchiectasis, non-tuberculous mycobacterial lung disease, pulmonary vascular disease
排除标准
- •Patients with previous history of lung cancer
- •Patients who have been diagnosed with other malignancy within 5 years
- •Unstable vital status
- •Active pulmonary tuberculosis
- •Infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
结局指标
主要结局
Diagnostic sensitivity of ctDNA methylation sequencing
时间窗: 2 year
Using pathologic diagnosis of lung cancer as gold standard, diagnostic sensitivity of ctDNA methylation will be compared with that of tumor markers.
Diagnostic specificity of ctDNA methylation sequencing
时间窗: 2 year
Using pathologic diagnosis of lung cancer as gold standard, diagnostic specificity of ctDNA methylation will be compared with that of tumor markers.
次要结局
- Negative predictive value of ctDNA methylation sequencing(2 year)
- Positive predictive value of ctDNA methylation sequencing(2 year)
- Diagnostic accuracy of ctDNA methylation sequencing(2 year)
研究者
Sang-Won Um
Professor
Samsung Medical Center