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Evaluation of Immune Cell Markers in Diagnosis of Tuberculosis

Evaluation of TB-antigen Responsive T Cell Markers in Diagnosis of Tuberculosis and Extrapulmonary Tuberculosis

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04148053
Enrollment
500
Registered
2019-11-01
Start date
2018-11-01
Completion date
2020-03-01
Last updated
2019-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis Infection

Brief summary

Diagnosis of active and latent pulmonary tuberculosis, as well as extrapulmonary tuberculosis, is still a major challenge of TB control in China. This observational study aims to evaluate TB-antigen responsive T cell markers in the diagnosis of tuberculosis and extrapulmonary tuberculosis and try to find new prompt and cost-effective laboratory tests for active TB screening.

Detailed description

The enrolled patients will be grouped into active or latent tuberculosis according to the bacteriological evidence of TB. The TB-antigen responsive T cell markers will be examined. The performance of each T cell marker for the diagnosis of active TB will be systematically evaluated.

Interventions

DIAGNOSTIC_TESTTB-antigen responsive T cell markers

A blood test including a series of T cell markers which are responsive to TB antigens

Sponsors

Tongji University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
7 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

* any patients suspicious of TB infection * TB culture and Xpert test required * Chest X-ray required

Exclusion criteria

* anti-TB therapy before the sample collection.

Design outcomes

Primary

MeasureTime frameDescription
Positive rate and negative rate2-3 month after samplingEvaluation of the positive rate and negative rate for each T cell marker
Receiver operating characteristic curve2-3 month after samplingThe AUC of each T cell marker will be analyzed and compared

Countries

China

Contacts

Primary ContactBO SU, Dr
su_bo_s@hotmail.com86-021-65115006

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026