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临床试验/NCT02965391
NCT02965391已完成不适用

Dynamic Changes and Surveillance of Circulating Tumor DNA in Surgical Non-small Cell Lung Cancer Patients

Peking University People's Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Half-life of circulating tumor DNA after surgery

研究概览

简要总结

Previous study showed circulating tumor DNA levels reflect the total systemic tumor burden. Circulating tumor DNA levels should decrease after complete surgery and could be increase as tumor recurrence. Few study investigated the half time of circulating tumor DNA in lung cancer patients that no criterion has been established of how to use it for surveillance.

详细描述

For lung cancer patients who received surgery, multiple time of plasma will be collected before or after surgery. A series of mutations will be detected in plasma before surgery based on next generation sequencing. The positive mutation will be traced after surgery and in follow up.

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

入选标准

  • Suspected lung cancer before surgery
  • No malignant tumor history within the past 5 years
  • The pulmonary nodule is not pure ground glass opacity
  • Patients must have given written informed consent

排除标准

  • Multiple primary lung cancer
  • R1,R2 resection
  • Histology confirmed not non-small cell lung cancer
  • Unqualified blood samples

结局指标

主要结局

Half-life of circulating tumor DNA after surgery

时间窗: 3 months

次要结局

  • Correlation of circulating tumor DNA level after surgery with clinical features(3 months)
  • The variation of circulating tumor DNA level before and after surgery(3 months)
  • Correlation of circulating tumor DNA level after surgery with tumor recurrence(3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chen KeZhong

Principal Investigator

Peking University People's Hospital

研究点 (1)

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