Evaluation of Immune Cell Markers in Diagnosis of Tuberculosis

Tuberculosis Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04148053
• Other study ID #: CTB18001
• Status: Recruiting
• Start date: November 1, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: October 2019
• Source: Tongji University
• Contact: BO SU, Dr
• Phone: 86-021-65115006
• Email: su_bo_s[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 1, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Latent Tuberculosis
• Tuberculosis
• Tuberculosis Infection

Intervention

Diagnostic Test:
• TB-antigen responsive T cell markers
A blood test including a series of T cell markers which are responsive to TB antigens

Locations

Country	Name	City	State
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Tongji University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive rate and negative rate	Evaluation of the positive rate and negative rate for each T cell marker	2-3 month after sampling
Primary	Receiver operating characteristic curve	The AUC of each T cell marker will be analyzed and compared	2-3 month after sampling