Evaluation of Immune Cell Markers in Diagnosis of Tuberculosis

Tongji University

Status: Unknown

Conditions: Tuberculosis Infection

Treatments: Diagnostic Test: TB-antigen responsive T cell markers

Study type: Observational

Funder types: Other

Identifiers

NCT04148053

CTB18001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 7 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

500 participants in 2 patient groups

Active TB

Description:

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.

Treatment:

Diagnostic Test: TB-antigen responsive T cell markers

Latent TB

Description:

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.

Treatment:

Diagnostic Test: TB-antigen responsive T cell markers