Diagnostic and Monitoring Significance of Circulating Tumor DNA (ctDNA) Methylation Analysis by Next-Generation Sequencing in Benign and Malignant Pulmonary Nodules
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10,560
- 试验地点
- 23
- 主要终点
- The diagnostic performance of the blood-based assay for differentiating benign and malignant pulmonary nodules early using circulating tumor DNA (ctDNA) methylation analysis by next-generation sequencing (NGS)
研究概览
简要总结
AnchorDx is using circulating tumor DNA (ctDNA) methylation analysis by next-generation sequencing (NGS) to develop a blood-based assay for differentiating benign and malignant pulmonary nodules early. The purpose of this study is to evaluate the diagnostic performance of this assay in patients with pulmonary nodules.
详细描述
This is a prospective, multi-center, observational cohort study and seeks to enroll 10,560 participants with pulmonary nodules smaller than 3 cm in diameter from 21 hospitals in China. All participants will be followed up with chest CT or low-dose computed tomography (LDCT) scans for 2-3 years ( baseline, 3 months, 6 months, 12 months, 24 months and 36 months). Their blood samples, CT or LDCT scans data, and clinical data will be collected at each visit and Formalin-fixed paraffin-embedded (FFPE) tissues will be collected when participants who receive pneumonectomy or percutaneous lung biopsy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 Years and older
- •pulmonary nodules diagnosed by chest CT or low-dose computed tomography (LDCT) scans
- •non-calcified pulmonary nodules with the diameter between 5mm to 30mm
- •including solid nodules, mixed ground-glass opacity nodules and pure ground-glass opacity lung modules
- •new cases of pulmonary nodules or diagnosed within 60 days prior to enrollment
- •agree to finish the Patient Pulmonary History Questionnaire
- •agree to be followed up for 2-3 years
- •agree to provide a written informed consent
排除标准
- •pregnant or lactating women
- •received any pneumonectomy or percutaneous lung biopsy before enrollment
- •recipients of blood transfusions within 30 days prior to enrollment
- •patients with tumors identified within 2 years prior to enrollment except non-melanoma skin cancer
- •fail to understand or provide a written informed consent
结局指标
主要结局
The diagnostic performance of the blood-based assay for differentiating benign and malignant pulmonary nodules early using circulating tumor DNA (ctDNA) methylation analysis by next-generation sequencing (NGS)
时间窗: 3 Years
The efficacy of the blood-based ctDNA methylation assay comparing with pathologic diagnosis, the gold standard, and CT/LDCT diagnosis, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV).
次要结局
- The diagnostic and monitoring significance of routine tests integrating with ctDNA methylation analysis by NGS in differentiating benign and malignant pulmonary nodules(3 Years)