Evaluation of Immune Cell Markers in Diagnosis of Tuberculosis

NCT ID: NCT04148053

Last Updated: 2019-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-01

Study Completion Date

2020-03-01

Brief Summary

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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

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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.

Conditions

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Tuberculosis Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Active TB

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.

TB-antigen responsive T cell markers

Intervention Type DIAGNOSTIC_TEST

A blood test including a series of T cell markers which are responsive to TB antigens

Latent TB

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.

TB-antigen responsive T cell markers

Intervention Type DIAGNOSTIC_TEST

A blood test including a series of T cell markers which are responsive to TB antigens

Interventions

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TB-antigen responsive T cell markers

A blood test including a series of T cell markers which are responsive to TB antigens

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tongji University

OTHER

Sponsor Role lead

Responsible Party

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Caicun Zhou

Director, Department of Thoracic Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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BO SU, Dr

Role: CONTACT

86-021-65115006 ext. 3039

Facility Contacts

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BO SU, Dr.

Role: primary

86-021-65115006 ext. 3039

Other Identifiers

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CTB18001

Identifier Type: -

Identifier Source: org_study_id

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