Evaluation of Immune Cell Markers in Diagnosis of Tuberculosis
Evaluation of TB-antigen Responsive T Cell Markers in Diagnosis of Tuberculosis and Extrapulmonary Tuberculosis
1 other identifier
observational
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2018
CompletedFirst Submitted
Initial submission to the registry
October 29, 2019
CompletedFirst Posted
Study publicly available on registry
November 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedNovember 1, 2019
October 1, 2019
1.2 years
October 29, 2019
October 31, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Positive rate and negative rate
Evaluation of the positive rate and negative rate for each T cell marker
2-3 month after sampling
Receiver operating characteristic curve
The AUC of each T cell marker will be analyzed and compared
2-3 month after sampling
Study Arms (2)
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.
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.
Interventions
A blood test including a series of T cell markers which are responsive to TB antigens
Eligibility Criteria
Any patients suspicious of TB infection
You may qualify if:
- any patients suspicious of TB infection
- TB culture and Xpert test required
- Chest X-ray required
You may not qualify if:
- anti-TB therapy before the sample collection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200123, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Department of Thoracic Oncology
Study Record Dates
First Submitted
October 29, 2019
First Posted
November 1, 2019
Study Start
November 1, 2018
Primary Completion
December 31, 2019
Study Completion
March 1, 2020
Last Updated
November 1, 2019
Record last verified: 2019-10