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Development and evaluation of a novel diagnostic technique for tuberculosis based on tongue swab

Development and evaluation of a novel diagnostic technique for tuberculosis based on tongue swab

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500101287
Enrollment
Unknown
Registered
2025-04-23
Start date
2024-08-19
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

tuberculosis disease

Interventions

Sponsors

Beijing Chest Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Age >=18 years old; (2) meet the clinical diagnostic criteria for suspected tuberculosis, including persistent cough, sputum, fever, night sweats, weight loss and other typical symptoms, as well as chest X-ray or CT examination showing abnormal lung images; (3) had not received anti-TB drugs before the start of the study, or had stopped taking them for at least two weeks; (4) Non-TB positive respiratory patients should be ruled out by clinical diagnosis and testing. (5) Fully understand the purpose, process, risks and benefits of the study, and voluntarily sign the informed consent; (6) Can cooperate with the collection of tongue swabs and sputum samples to ensure the integrity and reliability of the samples.

Exclusion criteria

Exclusion criteria: (1) Patients who are being treated for TB or who have taken anti-TB antibiotics in the past 2 weeks; (2) Patients with known immunodeficiency diseases; (3) Unwillingness or inability to provide informed consent. (4) Tongue swab samples considered by the investigator to be excluded

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;

Secondary

MeasureTime frame
negative predicative value;Positive predicative value;

Countries

China

Contacts

Public ContactPang Yu

Beijing Chest Hospital Affiliated to Capital Medical University

pangyupound@163.com+86 138 1009 8209

Outcome results

None listed

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