The Clinical Applications of Multiplex Analysis of Circulating Tumor DNA Biomarkers in Lung Cancer Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- The sensitivity and specificity of multiplex peripheral blood ctDNA biomarkers in the diagnosis of non-small cell lung cancer
研究概览
简要总结
Lung cancer is the leading cause of cancer-related death in China. This study will explore the applications of multiplex analysis of circulating tumor DNA biomarkers for diagnosis and surveillance of lung cancer patients
详细描述
Non-small cell lung cancer (NSCLC) constitutes about 85% of all newly diagnosed cases of lung cancer and continues to be the leading cause of cancer-related deaths worldwide.Early diagnosis and monitoring tumor recurrence after surgery are still far from satisfying.
Circulating tumor DNA(ctDNA) detection has been proved to be feasible in early stage NSCLC in previous studies.Both genomic mutation and methylation a promising biomarker.Therefore,this study will perform multiplex detection of ctDNA,analysing mutations, methylation and other biomarkers,focusing on the early diagnosis and postoperative surveillance for NSCLC patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign informed consent and consent to participate in this study;
- •Found small nodules in pulmonary by CT and prepare for surgery;
排除标准
- •Malignant tumor history within the past 5 years;
- •Receiving chemotherapy, radiotherapy or targeted therapy before surgery;
- •No matching tissue or blood samplesUnqualified blood samples
- •Lesion is pure ground glass opacity.
结局指标
主要结局
The sensitivity and specificity of multiplex peripheral blood ctDNA biomarkers in the diagnosis of non-small cell lung cancer
时间窗: 12 months
次要结局
- Comparing the sensitivity and specificity of each peripheral blood biomarkers for the diagnosis of non-small cell lung cancer(12 months)
- The sensitivity and specificity of multiplex peripheral blood ctDNA biomarkers for tumor relapse detection(36 months)
- Lead time of tumor relapse detection by multiplex ctDNA biomarkers than radiographic approaches(36 months)
研究者
Jun Wang
Chief，Thoracic Surgery Service
Peking University People's Hospital