跳至主要内容
临床试验/NCT01149187
NCT01149187Unknown不适用

Usefulness of Interferon-gamma Release Assay in Diagnosing Pulmonary Nodules

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2010年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
400
试验地点
1
主要终点
Positive rate of the interferon-gamma release assay

研究概览

简要总结

Among the causes of the solitary pulmonary nodule (SPN), benign causes including tuberculosis was noted on 15 to 60 percents in various studies.

Although the characteristics of chest imaging is helpful in diagnosis and percutaneous needle biopsy for pulmonary nodule has been represented high diagnostic yield in many reports, but still surgical biopsy has been needed in definite diagnosis of pulmonary nodules in many cases.

The aim of this study is to evaluate the usefulness of interferon-gamma release assay in addition to the percutaneous needle biopsy, in diagnosis of pulmonary nodules.

详细描述

Among the patients who failed to diagnosis by percutaneous needle biopsy and needed to have Surgical biopsy, thirty percents of the patients were diagnosed as benign nodules and about six percents were diagnosed as tuberculosis in Seoul National University Hospital during 2007-2008.

The investigators want to know whether conducting an interferon-gamma release assay in addition to percutaneous needle biopsy is helpful in diagnosis of lung nodules.

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

  • Age> 18 years
  • in patients with solitary pulmonary nodule
  • who had percutaneous needle biopsy for diagnosis of lung nodule

排除标准

  • patients who do not agree the study enrollment

结局指标

主要结局

Positive rate of the interferon-gamma release assay

时间窗: within 36hrs after blood sampling

the result of the interferon-gamma release assay is reported in three different categories as positive, negative or indeterminate. We want to know whether the positive rate of the interferon-gamma release asssay would be significantly different according to the pathologic diagnosis of lung nodules confirmed by percutaneous needle biopsy.

次要结局

  • Positive rate of the Tuberculin skin test(48hours after tuberculin skin test)

研究者

申办方类型
Other

研究点 (1)

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