Usefulness of Interferon-gamma Release Assay in Diagnosing Pulmonary Nodules
1 other identifier
observational
400
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2010
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 21, 2010
CompletedFirst Posted
Study publicly available on registry
June 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJune 23, 2010
June 1, 2010
6 months
June 21, 2010
June 22, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Positive rate of the Tuberculin skin test
48hours after tuberculin skin test
Study Arms (1)
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.
Eligibility Criteria
Among the inpatients who got percutaneous needle biopsy for pulmonary nodule during the study periods are going to be enrolled.
You may qualify if:
- Age\> 18 years
- in patients with solitary pulmonary nodule
- who had percutaneous needle biopsy for diagnosis of lung nodule
You may not qualify if:
- patients who do not agree the study enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Young Whan Kim
Seoul, 110-744, South Korea
Young Whan Kim
Seoul, 110-744, South Korea
Biospecimen
the investigaters will use the whole blood sample for interferon-gamma release assay.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 21, 2010
First Posted
June 23, 2010
Study Start
June 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
June 23, 2010
Record last verified: 2010-06