Solitary Pulmonary Nodule Clinical Trial
Official title:
Usefulness of Interferon-gamma Release Assay in Diagnosing Pulmonary Nodules
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.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age> 18 years - in patients with solitary pulmonary nodule - who had percutaneous needle biopsy for diagnosis of lung nodule Exclusion Criteria: - patients who do not agree the study enrollment |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Young Whan Kim | Seoul | |
Korea, Republic of | Young Whan Kim | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Positive rate of the interferon-gamma release assay | 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. | within 36hrs after blood sampling | No |
Secondary | Positive rate of the 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. | 48hours after tuberculin skin test | Yes |
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