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Clinical Study on Novel Peripheral Blood-Based Tests in the Diagnosis and Therapeutic Effect Evaluation of Tuberculosis

Clinical Study on Novel Peripheral Blood-Based Tests in the Diagnosis and Therapeutic Effect Evaluation of Tuberculosis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800019966
Enrollment
Unknown
Registered
2018-12-10
Start date
2019-01-01
Completion date
Unknown
Last updated
2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis

Interventions

Gold Standard:AFB, BACTEC MGIT 960, Chest imaging examination, histopathology.
Index test:Esat-6,&#32
CFP-10,&#32
AG85A,&#32
CD38&#32
CD27,&#32
INF-?.

Sponsors

Shanghai Pulmonary Hospital, Tongji University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Initial treatment of tuberculosis group: no history of tuberculosis, chest has the characteristics of tuberculosis, exclude other lung disease, and meet one of the following diagnostic criteria: (1) tuberculosis antibody positive; (2) IGRA positive; (3) PPD strong positive; (4) pathogenic test positive; (5) intralesional lesions pathological tissue or molecular pathological diagnosis of tuberculosis. 2. Initial treatment of extrapulmonary tuberculosis group: no history of tuberculosis, and diagnosis of extrapulmonary tuberculosis, including lymph node Nuclear, bone tuberculosis, tuberculous peritonitis and tuberculous meningitis, without pulmonary lesions, the diagnosis meets relevant standards; 3. Close contacts of tuberculosis: close contacts of newly diagnosed patients with dysentery (more than 6 hours a day, even Continued for two months) and IGRA positive, no active lesions in the lungs and exclusion of extrapulmonary tuberculosis; 4. Non-tuberculosis group: patients with other lung diseases except tuberculosis; 5. Healthy control group: IGRA negative healthy controls.

Exclusion criteria

Exclusion criteria: Primary or secondary immunodeficiency patients, including HIV, long-term use of hormones and patients with immune diseases.

Design outcomes

Primary

MeasureTime frame
Esat-6;CFP-10;AG85A;CD38;CD27;INF-?;

Countries

China

Contacts

Public ContactWei Sha

Shanghai Pulmonary Hospital, Tongji University

shfksw@126.com+86 13671758200

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026