Tuberculosis Clinical Trial
Official title:
Evaluation of the 4th Generation QuantiFERON-TB Test (QFT-Plus) for the Detection of Tuberculosis Infection
| NCT number | NCT02687529 |
| Other study ID # | CST001_USA7 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 27, 2015 |
| Est. completion date | May 26, 2016 |
| Verified date | June 2019 |
| Source | QIAGEN Gaithersburg, Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
To compare the positivity rate of the investigational assay to the currently approved QuantiFERON-TB Gold In-Tube assay.
| Status | Completed |
| Enrollment | 66 |
| Est. completion date | May 26, 2016 |
| Est. primary completion date | November 7, 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
Low Risk and Known Risk Cohorts Inclusion Criteria: - Compensated and uncompensated members (current or future) of the Department of Veterans Affairs with no identified symptoms of active TB disease - Age greater than 18 years or less than 80 years. Exclusion Criteria: - Currently taking therapy for active tuberculosis or latent TB infection for more than 14 days. |
| Country | Name | City | State |
|---|---|---|---|
| United States | VA Palo Alto Health Care System (VAPAHCS) | Palo Alto | California |
| Lead Sponsor | Collaborator |
|---|---|
| QIAGEN Gaithersburg, Inc |
United States,
Lewinsohn DA, Winata E, Swarbrick GM, Tanner KE, Cook MS, Null MD, Cansler ME, Sette A, Sidney J, Lewinsohn DM. Immunodominant tuberculosis CD8 antigens preferentially restricted by HLA-B. PLoS Pathog. 2007 Sep 21;3(9):1240-9. — View Citation
QuantiFERON-TB Gold Package Insert (DOC. No. US05990301L). March 2013. QIAGEN Inc.
Shams H, Klucar P, Weis SE, Lalvani A, Moonan PK, Safi H, Wizel B, Ewer K, Nepom GT, Lewinsohn DM, Andersen P, Barnes PF. Characterization of a Mycobacterium tuberculosis peptide that is recognized by human CD4+ and CD8+ T cells in the context of multiple HLA alleles. J Immunol. 2004 Aug 1;173(3):1966-77. — View Citation
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|---|---|---|---|---|
| Primary | Number of Participants With Concordant CST001 Assay Results for All Replicates Across Three Testing Sites | To demonstrate the reproducibility of the CST001 assay between 3 external laboratories with 2 operators per site. | 1 day (At time of enrollment) |
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