An observational study in Tuberculosis Infection, sponsored by Tongji University. Status unknown at 1 site in China. Open to participants aged 7 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-01.
Sponsored by Tongji University · Observational
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.
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.
203 studies on the registry are indexed under Latent Tuberculosis; 45 are open to participants now.
This study's planned enrollment of 500 is above the median of 227 across 76 observational studies indexed under Latent Tuberculosis.
Browse Latent Tuberculosis studies →Tongji University is the lead sponsor of 40 studies on the registry; 12 are open to participants now.
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Any patients suspicious of TB infection
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Exclusion Criteria:
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
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
Positive rate and negative rate
Evaluation of the positive rate and negative rate for each T cell marker
Time frame: 2-3 month after sampling
Receiver operating characteristic curve
The AUC of each T cell marker will be analyzed and compared
Time frame: 2-3 month after sampling
Plan to share: Undecided — The sharing of individual participant data will be decided by the sponsor after the accomplishment of the study.
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This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Tongji University