The Usefulness of Interferon-γ Release Assays and Tuberculin Skin Test for Detection of Latent Tuberculosis Infection
Evaluation of the Usefulness of Interferon-γ Release Assays and Tuberculin Skin Test for Detection of Latent Mycobacterium Tuberculosis Infection in Korean Patients With Rheumatic Diseases
1 other identifier
observational
2,000
1 country
1
Brief Summary
The purposes of this study
- 1.to compare the positivity of tuberculin skin test(TST) and QuantiFERON-TB Gold (QFT-G), and determine the level of agreement between two tests in patients with rheumatic diseases
- 2.to evaluate the difference in the occurrence of active TB in patients who receive both QFT-G and TST compared with those who receive only TST for detecting of Latent tuberculosis infection(LTBI) who are candidates of TNF inhibitors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2012
1 active site
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
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 12, 2012
CompletedFirst Posted
Study publicly available on registry
September 14, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedSeptember 18, 2012
September 1, 2012
1.4 years
September 12, 2012
September 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The agreement between QuantiFERON-TB Gold(QFT-G) and tuberculin skin test(TST) as a screening test for latent tuberculosis infection(LTBI)
one year
Secondary Outcomes (1)
The correlation of the occurrence of active Tuberculosis and two tests (QuantiFERON-TB Gold (QFT-G) and tuberculosis skin test(TST))
one year
Eligibility Criteria
1\) Estimation of the positive rates and agreement between QFT-G and TST * Approximately 2,000 patients with rheumatic diseases who examined TST or QFT-G in Hanyang university hospital from 2004 to 2010 2) Determining the difference in the occurrence of active TB in the TNF inhibitor user according to the screening and the treatment of LTBI. * Approximately 400 patients with rheumatic diseases who received TST or QFT-G before using anti-TNF agents in Hanyang university hospital from 2004 to 2010
You may qualify if:
- patients with rheumatic diseases who examined TST or QFT-G in Hanyang university hospital from 2004 to 2010
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hanyang Universitylead
- Bristol-Myers Squibbcollaborator
Study Sites (1)
Hanyang University Hospital for rheumatic disease
Seoul, Sung-dong Gu, 133-792, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sang-cheol Bae, director
Hanyang University Hospital for Rheumatic Disease
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, MD, PhD, MPH
Study Record Dates
First Submitted
September 12, 2012
First Posted
September 14, 2012
Study Start
April 1, 2012
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
September 18, 2012
Record last verified: 2012-09