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临床试验/NCT03791034
NCT03791034招募中不适用

Prospective Feasibility Study of Cell Free Circulating Tumor DNA for the Diagnosis and Treatment Monitoring in Early-stage Non-small Cell Lung Cancer

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2017年8月28日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
700
试验地点
1
主要终点
Recurrence

研究概览

简要总结

The aim of the study is to evaluate whether peripheral circulating cell-free tumor DNA (cfDNA) can aid screening of recurrence after complete resection of early stage non-small cell lung cancer.

详细描述

During evolution of primary tumor, tumor cells can be released into the bloodstream. It has also been shown that circulating cell-free tumor DNA (cfDNA) is released from apoptotic or necrotic tumor cells. In a study of cfDNA level after surgery in colon cancer patients, they suggested that cfDNA could detect recurrence of cancer several months earlier than the conventional follow up studies. Following several reports have suggested that cfDNA can invade host cells and alter host cell biology to cause cancer metastasis.

In this regard, we will collect from non-small cell lung cancer patients cohort who underwent curative resection, and will evaluate whether peripheral cfDNA can aid early detection of cancer recurrence. We will also study the genomic signature of cfDNA to assess the relationship between cfDNA and clinical outcome of non-small cell lung cancer patients.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All subjects need to sign the informed consent form
  • All subjects have Non-small cell lung cancer which suspected on chest CT or confirmed pathologically preoperatively.
  • Non-small cell lung cancer have to confirmed pathologically after operation
  • Clinical stage I - IIIA by AJCC 7th staging system

排除标准

  • Have been undergone chemotherapy or radiotherapy due to non-small call lung cancer
  • Have been diagnosed any type of cancer other than cancer of skin, thyroid, uterine cervix with 3 years before enrollment
  • Recurrent lung cancer
  • Stage IIIB, IV by AJCC 7th staging system

结局指标

主要结局

Recurrence

时间窗: 24 months

Recurrence of primary tumor documented by diagnostic imaging with or without biopsy

次要结局

未报告次要终点

研究者

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

Jhingook Kim, MD

Professor

Samsung Medical Center

研究点 (1)

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