Usefulness of Interferon-gamma Release Assay in Diagnosing Pulmonary Nodules

Solitary Pulmonary Nodule Clinical Trial

Official title:

Usefulness of Interferon-gamma Release Assay in Diagnosing Pulmonary Nodules

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01149187
• Other study ID #: SeoulNUH-IGRA-01
• 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

• Multiple Pulmonary Nodules
• Solitary Pulmonary Nodule

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