Usefulness of Interferon-gamma Release Assay in Diagnosing Pulmonary Nodules

Sponsor
Seoul National University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01149187
Collaborator
(none)
400
2
6
200
33.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Usefulness of Interferon-gamma Release Assay in Diagnosing Pulmonary Nodules
    Study Start Date :
    Jun 1, 2010
    Anticipated Primary Completion Date :
    Dec 1, 2010
    Anticipated Study Completion Date :
    Dec 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Positive rate of the interferon-gamma release assay [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.

    Secondary Outcome Measures

    1. Positive rate of the Tuberculin skin test [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Young Whan Kim Seoul Korea, Republic of 110-744
    2 Young Whan Kim Seoul Korea, Republic of 110-744

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01149187
    Other Study ID Numbers:
    • SeoulNUH-IGRA-01
    First Posted:
    Jun 23, 2010
    Last Update Posted:
    Jun 23, 2010
    Last Verified:
    Jun 1, 2010
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 23, 2010