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
- any patients suspicious of TB infection
- TB culture and Xpert test required
- Chest X-ray required
- anti-TB therapy before the sample collection.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Positive rate and negative rate 2-3 month after sampling Evaluation of the positive rate and negative rate for each T cell marker
Receiver operating characteristic curve 2-3 month after sampling The AUC of each T cell marker will be analyzed and compared
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Shanghai Pulmonary Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai Pulmonary Hospital🇨🇳Shanghai, Shanghai, ChinaBO SU, Dr.Contact86-021-65115006su_bo_s@hotmail.comBo SU, DRPrincipal InvestigatorWEI SHA, DRSub InvestigatorYong Fan, DRSub InvestigatorXiaojun Yang, BSSub InvestigatorNa Wang, BSSub Investigator