Evaluation of Immune Cell Markers in Diagnosis of Tuberculosis

• Conditions: Tuberculosis Infection
• Interventions: Diagnostic Test: TB-antigen responsive T cell markers

• 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.

Study Timeline

• Study Start: 2018-11-01
• Status Verified: 2019-10
• Study First Submitted: 2019-10-29
• Study First Submitted QC: 2019-10-31
• Last Update Submitted: 2019-10-31
• Study First Posted: 2019-11-01
• Last Update Posted: 2019-11-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-03-01

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

Arm && Interventions

Group	Intervention	Description
Active TB	TB-antigen responsive T cell markers	Subjects met the following: 1. Either Pulmonary or Extra-pulmonary tuberculosis patients 2. TB Bacteriological evidence obtained by culture or Xpert MTB/RIF from at least 1 specimen.
Latent TB	TB-antigen responsive T cell markers	Subjects met the following: 1. TB Contact in history. 2. Chest X-ray suggestive of non-TB. 3. without any symptoms suggestive of TB. 4. TST and/or IGRA positive.

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

Trial Locations

Locations (1)

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, Shanghai, China