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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01149187
Other study ID # SeoulNUH-IGRA-01
Secondary ID
Status Recruiting
Phase N/A
First received June 21, 2010
Last updated June 22, 2010
Start date June 2010
Est. completion date December 2010

Study information

Verified date June 2010
Source Seoul National University Hospital
Contact Young Whan Kim, MD
Phone 82-2-2072-2856
Email ywkim@snu.ac.kr
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of Young Whan Kim Seoul
Korea, Republic of Young Whan Kim Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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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