A Prospective Study of Longitudinal Monitoring in Surgical Lung Cancer Patients by Circulating Tumor DNA and Its Methylation
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Correlation between patients' recurrence and quantitative detection of circulating tumor DNA (ctDNA) concentration, including the quantitative detection of ctDNA mutations and ctDNA aberrant methylation.
研究概览
简要总结
Conduct a prospective study to confirm the value of circulating tumor DNA and its aberrant methylation in longitudinal monitoring of surgical lung cancer patients.
详细描述
Studies have already demonstrated the feasibility of circulating tumor DNA as a surrogate to reveal tumor mutation status in lung cancer patients and a few researches have shown the potential ability of using circulating tumor DNA in surveillance. However, no study focused on the value of methylation status of circulating tumor DNA in the surveillance and no strict prospective study has been performed in surgical lung cancer patients.
The investigators plan to analyze the dynamic change of circulating tumor DNA and its methylation status longitudinally from preoperation to long term follow-up in surgical lung cancer patients, and compare assessment value between circulating tumor DNA detection with methylation , traditional imaging examinations and traditional blood tumor markers in the monitoring process.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 80 years
- •Lung cancer was suspected preoperatively.
- •Received curative surgical therapy
- •No malignant tumor history within the past 5 years
- •No being received any treatment prior to resection
- •Patients must have given written informed consent
排除标准
- •The pulmonary nodule is pure ground glass opacity
- •Unable to comply with the study procedure
- •The postoperative pathology is not NSCLC.
- •Unqualified blood samples
结局指标
主要结局
Correlation between patients' recurrence and quantitative detection of circulating tumor DNA (ctDNA) concentration, including the quantitative detection of ctDNA mutations and ctDNA aberrant methylation.
时间窗: 3 years
次要结局
- The concordance of ctDNA genomic and methylation status alterations detected in peripheral blood samples with those in matched tumor samples.(1 year)
- Correlation between disease free time and quantitative detection of ctDNA genomic alterations or methylation status alterations in patients who receives adjuvant therapy.(3 years)
- Leading time of tumor relapse detection by circulating tumor DNA and methylation status than traditional radiological methods.(3 years)
- The variation of aberrant methylated ctDNA concentration before surgery, 3 days after surgery and 1 month after surgery.(1 year)
研究者
Jun Wang
Chief，Thoracic Surgery Service
Peking University People's Hospital