Evaluation of Immune Cell Markers in Diagnosis of Tuberculosis

October 31, 2019 updated by: Caicun Zhou, Tongji University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200123
        • Recruiting
        • Shanghai Pulmonary Hospital
        • Contact:
        • Principal Investigator:
          • Bo SU, DR
        • Sub-Investigator:
          • WEI SHA, DR
        • Sub-Investigator:
          • Yong Fan, DR
        • Sub-Investigator:
          • Xiaojun Yang, BS
        • Sub-Investigator:
          • Na Wang, BS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Any patients suspicious of TB infection

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: TB-antigen responsive T cell markers
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.
Diagnostic test: TB-antigen responsive T cell markers
A blood test including a series of T cell markers which are responsive to TB antigens

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

October 29, 2019

First Submitted That Met QC Criteria

October 31, 2019

First Posted (Actual)

November 1, 2019

Study Record Updates

Last Update Posted (Actual)

November 1, 2019

Last Update Submitted That Met QC Criteria

October 31, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTB18001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The sharing of individual participant data will be decided by the sponsor after the accomplishment of the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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