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Tuberculosis gene expression profile discovery study

Tuberculosis gene expression profile discovery study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300072295
Enrollment
Unknown
Registered
2023-06-08
Start date
2022-06-30
Completion date
Unknown
Last updated
2023-06-18

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

Conditions

tuberculosi

Interventions

Gold Standard:The gold standard for the diagnosis of tuberculosis is a positive culture for Mycobacterium tuberculosis, which can be complemented by other clinical symptoms and a comprehensive medical
Index test:transcriptome sequencing, single-cell histology and ?-interferon gamma release assay(IGRA)

Sponsors

Shenzhen Bao'an People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Healthy control (HC): Healthy people with no clinical symptoms of active TB, negative imaging and negative IGRAs for TB specificity. 2. Latently infected tuberculosis patients (LTBI): Healthy people with no clinical symptoms of active TB, negative imaging and positive IGRAs for TB specificity. 3. Patients with tuberculosis (SPTB): clinical symptoms and imaging suggestive of tuberculosis, 2 sputum smears of Mycobacterium tuberculosis, positive culture or PCR test, and effective anti-tuberculosis treatment. 4. If the ? interferon release test is positive or clinically highly suspected of pulmonary tuberculosis, there is significant improvement in imaging after anti-tuberculosis treatment, indicating the development of active pulmonary tuberculosis.

Exclusion criteria

Exclusion criteria: 1, there are major diseases such as cancer 2, major mental illness is difficult to cooperate with the completion of all tests 3, ? interferon release test test experiments and other clinical symptoms and test results are inconsistent 4, immunosuppression (such as long-term use of hormones and immunosuppressants, receiving organ transplants, combined with HIV infection) caused by false negatives

Design outcomes

Primary

MeasureTime frame
Cycle threshold;Gene expression;

Secondary

MeasureTime frame
IFN-gamma release concentration;

Countries

China

Contacts

Public ContactYuzhong Xu

Shenzhen Bao'an People's Hospital

254501651@qq.com+86 134 1847 3391

Outcome results

None listed

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