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A Novel Multi-Epitope Fusion Protein for Serodiagnosis and Clinical Severity Assessment of Tuberculosis

A Novel Multi-Epitope Fusion Protein for Serodiagnosis and Clinical Severity Assessment of Tuberculosis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600116401
Enrollment
Unknown
Registered
2026-01-09
Start date
2025-10-01
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Patients with tuberculosis

Interventions

Non-tuberculous pulmonary infection group:None
Pulmonary tuberculosis group:None

Sponsors

Fifth Affiliated Hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Tuberculosis Group: (251 confirmed TB patients at Zhongshan University Fifth Affiliated Hospital, Dec 1, 2022 – Aug 31, 2023) (1) Diagnosed according to WS288-2017 "Diagnostic Criteria for Tuberculosis" using bacteriological, pathological, chest imaging, and molecular biological methods. (2) Age >=18 and =18 and =18 years.

Exclusion criteria

Exclusion criteria: Tuberculosis Patient Group: 1. Clinical data information is missing; 2. The drug sensitivity test result shows multi-drug resistant tuberculosis bacteria; 3. The nucleic acid test or culture result shows nontuberculous mycobacteria; 4. Patients with autoimmune related diseases, tumors, AIDS, or infections from other systems; Control Group:1.Clinical data information is missing; 2.Patients with autoimmune related diseases, tumors, AIDS, or infections from other systems;

Design outcomes

Primary

MeasureTime frame
Measure the levels of serum anti-Mtb6-Avi fusion protein antibodies;

Secondary

MeasureTime frame
Demographic data: age, gender, ethnicity, occupation, name;;Medical history and physical examination (including chief complaint, vital signs, height, weight, comprehensive systemic physical examination; past medical history, personal history, family history);Thoracic imaging (chest X-ray, chest CT);

Countries

China

Contacts

Public ContactLiu Xi

Fifth Affiliated Hospital, Sun Yat-Sen University

liuxi26@mail.sysu.edu.cn+86 756 2528527

Outcome results

None listed

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