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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date June 2019
Source QIAGEN Gaithersburg, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To compare the positivity rate of the investigational assay to the currently approved QuantiFERON-TB Gold In-Tube assay.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
CST001


Locations

Country Name City State
United States VA Palo Alto Health Care System (VAPAHCS) Palo Alto California

Sponsors (1)

Lead Sponsor Collaborator
QIAGEN Gaithersburg, Inc

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

Outcome

Type Measure Description Time frame Safety issue
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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