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Usefulness of Interferon-gamma Release Assay in Diagnosing Pulmonary Nodules

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2010 by Seoul National University Hospital.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01149187
First received: June 21, 2010
Last updated: June 22, 2010
Last verified: June 2010
  Purpose

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
Solitary Pulmonary Nodule

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Usefulness of Interferon-gamma Release Assay in Diagnosing Pulmonary Nodules

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Positive rate of the interferon-gamma release assay [ Time Frame: within 36hrs after blood sampling ] [ Designated as safety issue: No ]
    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:
  • Positive rate of the Tuberculin skin test [ Time Frame: 48hours after tuberculin skin test ] [ Designated as safety issue: Yes ]
    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.


Biospecimen Retention:   Samples With DNA
the investigaters will use the whole blood sample for interferon-gamma release assay.

Estimated Enrollment: 400
Study Start Date: June 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Among the inpatients who got percutaneous needle biopsy for pulmonary nodule during the study periods are going to be enrolled.
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01149187

Locations
Korea, Republic of
Young Whan Kim
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
  More Information

Responsible Party: Young Whan Kim/professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01149187     History of Changes
Other Study ID Numbers: SeoulNUH-IGRA-01 
Study First Received: June 21, 2010
Last Updated: June 22, 2010
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Solitary Pulmonary Nodule
Multiple Pulmonary Nodules
Lung Diseases
Respiratory Tract Diseases
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Interferons
Interferon-gamma
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on December 06, 2016