Clinical Trial: Usefulness of Interferon-gamma Release Assay in Diagnosing Pulmonary Nodules

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Observational

Official Title: Usefulness of Interferon-gamma Release Assay in Diagnosing Pulmonary Nodules

Brief Summary:

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.


Detailed Summary:

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.


Sponsor: Seoul National University Hospital

Current Primary Outcome: Positive rate of the interferon-gamma release assay [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Positive rate of the Tuberculin skin test [ Time Frame: 48hours after tuberculin skin test ]

We will conduct Tuberculin skin test and evaluate the whether the positive rate of the Tuberculin skin test would be different according to the pathologic diagnosis of lung nodules confirmed by percutaneous needle biopsy.


Original Secondary Outcome: Same as current

Information By: Seoul National University Hospital

Dates:
Date Received: June 21, 2010
Date Started: June 2010
Date Completion: December 2010
Last Updated: June 22, 2010
Last Verified: June 2010