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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active TB | Subjects met the following:
|
| |
| Latent TB | Subjects met the following:
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|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TB-antigen responsive T cell markers | Diagnostic Test | A blood test including a series of T cell markers which are responsive to TB antigens |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Any patients suspicious of TB infection
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BO SU, Dr | Contact | 86-021-65115006 | 3039 | su_bo_s@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Pulmonary Hospital | Recruiting | Shanghai | Shanghai Municipality | 200123 | China |
The sharing of individual participant data will be decided by the sponsor after the accomplishment of the study.
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| ID | Term |
|---|---|
| D055985 | Latent Tuberculosis |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
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| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000085343 | Latent Infection |