A Prospective Study of Circulating Tumor DNA Detection in Surveillance for Stage ⅢA Non-small-cell Lung Cancer Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 145
- 试验地点
- 3
- 主要终点
- Lead time of tumor relapse detection by blood or urine circulation tumor DNA than radiographic approaches
研究概览
简要总结
Conduct a prospective study to confirm blood and urine ctDNA detection value in non-small-cell lung cancer patients.
详细描述
Studies have shown the feasibility of detecting mutation status by blood and urine circulating tumor DNA (ctDNA)in non-small cell lung cancer (NSCLC) patients. However, no prospective has been conducted for usage of ctDNA in postoperative surveillance of NSCLC patients.
We plan to compare tumor makers and radiographic approaches with blood and urine ctDNA in surveillance to assess the lead time of postoperative tumor relapse in stage ⅢA NSCLC patients. And evaluate the correlation between ctDNA level with tumor relapse or metastasis.
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
- •Undergo radical surgery（R0 resection）
- •Histologically confirmed diagnosis of stage ⅢA non-small cell lung cancer
- •Positive Driver mutation(EGFR、PTEN、PIK3CA、BRAF、K-RAS、Her2) in tumor tissue
- •Blood or urine circulating tumor detect the driver mutation detected in tumor tissue
- •Patients must have given written informed consent
排除标准
- •Unable to comply with the study procedure
- •Malignant tumor history within the past 5 years
- •Patients who received any treatment prior to resection
- •R1 or R2 resection
- •Coexisting small cell lung cancer
- •Received target drug therapy after surgery
- •Unqualified blood or urine samples
结局指标
主要结局
Lead time of tumor relapse detection by blood or urine circulation tumor DNA than radiographic approaches
时间窗: 4 years
次要结局
- Lead time of tumor relapse detection by blood or urine circulation tumor DNA than tumor markers(4 years)
- The concordance of ctDNA genomic alterations detection in peripheral blood and urine with those in matched tumor sample(1 year)
- Correlation of blood and urine ctDNA concentration before surgery with clinical features and prognosis(4 years)
- Correlation of blood and urine ctDNA concentration 3 days after surgery with clinical features and prognosis(4 years)
- CtDNA predictive value between locoregional recurrence and distant metastasis(4 years)
研究者
Jun Wang
Chief，Thoracic Surgery Service
Peking University People's Hospital