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临床试验/NCT03479099
NCT03479099已完成不适用

Clinical Utility of Combined CTC and ctDNA Assay in the Diagnosis of Primary Lung Cancer

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2018年3月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
111
试验地点
1
主要终点
Diagnostic sensitivity of combined CTC and ctDNA

研究概览

简要总结

The purpose of this study is to assess clinical utility of combined circulating tumor cell (CTC) and circulating tumor DNA (ctDNA) in the diagnosis of primary lung cancer.

详细描述

The peripheral blood and tumor tissue samples are collected from the participants.CTC and ctDNA are analyzed from the blood samples.

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

入选标准

  • Patients with histology-proven lung cancer or a clinical suspicion of lung cancer
  • Age >=18, < 80 years
  • No previous history of cancer treatment within 5 years
  • Patients who agree to participate

排除标准

  • Patients who have been diagnosed with malignancy within 5 years
  • Patients with previous history of lung cancer
  • Patients who have uncontrolled coagulopathy

结局指标

主要结局

Diagnostic sensitivity of combined CTC and ctDNA

时间窗: 1 year

To compared the sensitivity of combined CTC and ctDNA with those of CTC and ctDNA alone in diagnosis of primary lung cancer

次要结局

  • Diagnostic accuracy of combined CTC and ctDNA(1 year)
  • Diagnostic specificity of CTC and ctDNA(1 year)

研究者

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

Sang-Won Um

Associate Professor

Samsung Medical Center

研究点 (1)

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