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Evaluation of Immune Cell Markers in Diagnosis of Tuberculosis

Conditions
Tuberculosis Infection
Registration Number
NCT04148053
Lead Sponsor
Tongji University
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
500
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Positive rate and negative rate2-3 month after sampling

Evaluation of the positive rate and negative rate for each T cell marker

Receiver operating characteristic curve2-3 month after sampling

The AUC of each T cell marker will be analyzed and compared

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Shanghai Pulmonary Hospital

🇨🇳

Shanghai, Shanghai, China

Shanghai Pulmonary Hospital
🇨🇳Shanghai, Shanghai, China
BO SU, Dr.
Contact
86-021-65115006
su_bo_s@hotmail.com
Bo SU, DR
Principal Investigator
WEI SHA, DR
Sub Investigator
Yong Fan, DR
Sub Investigator
Xiaojun Yang, BS
Sub Investigator
Na Wang, BS
Sub Investigator

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