Methylation of cfDNA in Diagnosing and Monitoring Benign and Malignant Pulmonary Nodule
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 401
- 试验地点
- 1
- 主要终点
- The efficacy of cfDNA methylation in the diagnosis of benign and malignant pulmonary nodules
研究概览
简要总结
Patients found pulmonary nodules by CT screening by will be enrolled in this study prospectively. Plasma cfDNA sequencing of these patients will be used to diagnose and monitor benign and malignant pulmonary nodules.
详细描述
This study prospectively included patients with pulmonary nodules (0.5-3 cm) diagnosed by CT. Methylation of plasma cfDNA in these patients will be performed. Evaluation of benign and malignant diagnostic efficacy of cfDNA methylation in pulmonary nodules with definite pathological findings. Pulmonary nodules that temporarily not require invasive examination will be performed CT follow-up and dynamically monitored methylation changes of cfDNA. And the methylation changes were to establish a model for the diagnosis and monitor of benign and malignant pulmonary nodules.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria:
- •Aged 40-80;
- •Lung nodules were detected by CT (≥5mm，≤3cm);
- •Patients fully understand the informed consent and can sign the informed consent in person.
排除标准
- •Exclusion criteria:
- •Patients diagnosed with malignant tumors in the past;
- •This image suggests pulmonary nodules with hilar or mediastinal lymph node enlargement；
- •Pulmonary nodules are suspected of intrapulmonary metastasis of lung cancer or other malignancies；
- •Past diseases or conditions that affect plasma cfDNA content, such as rheumatoid immunity and diseases of the blood system.
- •The researchers concluded that there were other conditions that made it inappropriate to participate in this study
结局指标
主要结局
The efficacy of cfDNA methylation in the diagnosis of benign and malignant pulmonary nodules
时间窗: 12 months
The sensitivity, specificity, positive predictive value, negative predictive value and accuracy are calculated according to standard definitions to evaluate the efficacy of cfDNA methylation in the diagnosis of benign and malignant pulmonary nodules .
次要结局
未报告次要终点
研究者
Jiayuan Sun
Chief Physician, Department of Pulmonary Medicine, Director, Department of Respiratory Endoscopy and Interventional Pulmonology
Shanghai Chest Hospital