TuberculosisNCT02256839
Evaluation of the QuantiFERON-TB Test.
An observational study of Tuberculosis, run by QIAGEN Gaithersburg, Inc at 1 site in United States.
Trial summary
To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- CST_001
- Type of treatment
- Medical device
- How many people
- 268 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Oct 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who have either low-exposure rist to tuberculosis or have non-tuberculous mycobacterial infections
Who may be able to join
- No identified risk factors for TB infection
- history of nontuberculous mycobacterial disease (pulmonary or extrapulmonary) in accordance with the 2007 ATS/IDSA criteria
Who cannot join
- Age less than 18 years or greater than 80 years
- Identified Risk Factors For TB Infection
- Non-tuberculous mycobacterial infection Group
- Age less than 18 years or greater than 80 years
- Identified Risk Factors For TB Infection
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Sciences University
Portland, Oregon, 97239
About this study
Official title: Evaluation of the 4th Generation QuantiFERON-TB Gold Test (CST001) for the Detection of Tuberculosis Infection
To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.
Read the detailed description
To compare the specificity of the CST001 assay to the QFT Gold Test in low TB exposure risk subjects and non-tuberculosis mycobacterial infections.
- Conditions
- Tuberculosis
- Being tested
- CST_001
- Keywords
- Tuberculosis, TB
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CST_001Device
| Study group | Role | What they receive |
|---|---|---|
| non TB infection | Group tested with CST_001 Receives: Device: CST_001 | |
| low exposure risk | Group tested with CST_001 Receives: Device: CST_001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day (At time of enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- QIAGEN Gaithersburg, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin Winthrop, MD, M.P.H, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02256839
- Sponsor's protocol ID
- CST001_USA4
- Status last verified
- Jun 2019
- First submitted
- 29 Sep 2014
- Last updated
- 1 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
QuantiFERON - TB Gold Package Insert (Doc. No. US05990301L). March 2013. Cellestis Inc.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the 4th Generation QuantiFERON-TB Gold Test (CST001) for the Detection of Tuberculosis Infection
- ClinicalTrials.gov ID
- NCT02256839
- Acronym / sponsor ID
- CST001_USA4
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, TB
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- QIAGEN Gaithersburg, IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 6 Oct 2014 (estimated)
- Results
- Posted 1 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.
Detailed description
To compare the specificity of the CST001 assay to the QFT Gold Test in low TB exposure risk subjects and non-tuberculosis mycobacterial infections.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non TB infection | – | Device: CST_001Group tested with CST_001 |
| low exposure risk | – | Device: CST_001Group tested with CST_001 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have either low-exposure rist to tuberculosis or have non-tuberculous mycobacterial infections
Key inclusion criteria (2 listed)
- No identified risk factors for TB infection
- history of nontuberculous mycobacterial disease (pulmonary or extrapulmonary) in accordance with the 2007 ATS/IDSA criteria
Key exclusion criteria (5 listed)
- Age less than 18 years or greater than 80 years
- Identified Risk Factors For TB Infection
- Non-tuberculous mycobacterial infection Group
- Age less than 18 years or greater than 80 years
- Identified Risk Factors For TB Infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CST_001 | Device | low exposure risk, non TB infection |
Primary outcome
Clinical Specificity of the CST001 Assay as Measured by the Number of Correctly Identified Actual Negatives
Time frame: 1 day (At time of enrollment)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundQuantiFERON - TB Gold Package Insert (Doc. No. US05990301L). March 2013. Cellestis Inc.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Winthrop, MD, M.P.H principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by QIAGEN Gaithersburg, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Specificity of the CST001 Assay as Measured by the Number of Correctly Identified Actual Negatives (time frame: 1 day (At time of enrollment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02256839, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2019; AzTrials last refreshed its copy on 29 Oct 2026.