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临床试验/NCT02607605
NCT02607605Unknown不适用

A Prospective, Observational Trial on the Diagnostic and Prognostic Value of Cell-free DNA in Advanced Lung Cancer With Leptomeningeal Metastases

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
10
试验地点
1
主要终点
positive rate between the cell-free DNA and cytological examination of cerebrospinal fluid

研究概览

简要总结

The primary purpose of this study is to compare the positive rate between the cell-free DNA and cytological examination of cerebrospinal fluid in Advanced lung cancer with leptomeningeal metastases.

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

入选标准

  • Patient who was confirmed primary lung cancer by pathologic histology or cytology
  • Adult patients (≥18 years and ≤75 years). ECOG Performance Status 0 or 1.Life expectancy of at least 12 weeks.
  • Clinical symptoms and imaging tests are highly suspicious of advanced lung cancer with leptomeningeal metastases
  • Without contraindications to lumbar puncture

排除标准

  • Patients who have primary benign or malignant brain tumor and metastatic malignant brain tumor
  • Patients who have contraindications to lumbar puncture
  • Serious uncontrolled systemic disease including active infection,uncontrolled hypertension,diabetes,unstable angina,congestive heart failure,myocardial infarction,severe arrhythmia which needs drugs,hepatic、renal and metabolic disease

结局指标

主要结局

positive rate between the cell-free DNA and cytological examination of cerebrospinal fluid

时间窗: 2 years

次要结局

  • The relationship between the number of cell-free DNA and OS(2 years)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Li-kun Chen

associate professor

Sun Yat-sen University

研究点 (1)

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