Evaluation of the QuantiFERON-TB Test.
Evaluation of the 4th Generation QuantiFERON-TB Gold Test (CST001) for the Detection of Tuberculosis Infection
1 other identifier
observational
268
1 country
1
Brief Summary
To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2014
Shorter than P25 for all trials
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
First Submitted
Initial submission to the registry
September 29, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedFirst Posted
Study publicly available on registry
October 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedResults Posted
Study results publicly available
August 1, 2019
CompletedAugust 1, 2019
June 1, 2019
1 year
September 29, 2014
September 18, 2018
June 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Specificity of the CST001 Assay as Measured by the Number of Correctly Identified Actual Negatives
To compare the clinical specificity of the CST001 assay to the QuantiFERON-TB Gold test in low TB exposure risk subjects and non TB infected subjects based on an assessment of known risk factors. These subjects had no identified risk factors of TB infection.
1 day (At time of enrollment)
Study Arms (2)
non TB infection
Group tested with CST\_001
low exposure risk
Group tested with CST\_001
Interventions
Eligibility Criteria
Patients who have either low-exposure rist to tuberculosis or have non-tuberculous mycobacterial infections
You may qualify if:
- No identified risk factors for TB infection
You may not qualify if:
- Age less than 18 years or greater than 80 years
- Identified Risk Factors For TB Infection
- Non-tuberculous mycobacterial infection Group
- history of nontuberculous mycobacterial disease (pulmonary or extrapulmonary) in accordance with the 2007 ATS/IDSA criteria
- Age less than 18 years or greater than 80 years
- Identified Risk Factors For TB Infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oregon Health & Sciences University
Portland, Oregon, 97239, United States
Related Publications (1)
QuantiFERON - TB Gold Package Insert (Doc. No. US05990301L). March 2013. Cellestis Inc.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Study Coordinator
- Organization
- QIAGEN Sciences
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin Winthrop, MD, M.P.H
Oregon Health and Science University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2014
First Posted
October 6, 2014
Study Start
October 1, 2014
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
August 1, 2019
Results First Posted
August 1, 2019
Record last verified: 2019-06