Usefulness of Interferon-gamma Release Assay in Diagnosing Pulmonary Nodules
Recruitment status was: Recruiting
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.
Solitary Pulmonary Nodule
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Usefulness of Interferon-gamma Release Assay in Diagnosing Pulmonary Nodules|
- Positive rate of the interferon-gamma release assay [ Time Frame: within 36hrs after blood sampling ] [ Designated as safety issue: No ]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.
- Positive rate of the Tuberculin skin test [ Time Frame: 48hours after tuberculin skin test ] [ Designated as safety issue: Yes ]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.
Biospecimen Retention: Samples With DNA
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||December 2010|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
IGRA in solitary pulmonary nodules
Inpatients who undergo percutaneous needle biopsy for diagnosis of pulmonary nodules in Seoul National University hospital for six months are going to be included. Patients who are not tolerable for PCNB or do not agree the enrollment of study will be excluded.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01149187
|Korea, Republic of|
|Young Whan Kim|
|Seoul, Korea, Republic of, 110-744|