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Sputum-free Diagnostis of TB
Sponsor: Research Center Borstel
Summary
The aim of this study is to identify new biomarkers that enable reliable, non-invasive diagnosis of tuberculosis (TB), including in patients who are unable to produce sputum. The study analyzes biomaterials (blood, urine, stool, sputum) collected from patients with suspected TB. Various diagnostic methods are applied to assess the feasibility of individual and combined biomarker tests. Participating patients will provide biomaterial samples (blood, urine, stool, sputum) once. No additional examinations or invasive procedures will be performed. Routine diagnostic procedures remain unaffected. This is a single-center, prospective observational study. Patients are enrolled as part of their clinical care at the University Medical Center Hamburg-Eppendorf.
Official title: Biomarker-guided Diagnosis of Tuberculosis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2025-06-06
Completion Date
2026-12
Last Updated
2025-08-15
Healthy Volunteers
No
Conditions
Interventions
Biomarker-guided diagnostic tests
mRNA-Signature from blood; immunophenotyping from blood; MBLA from sputum, PATHFAST-LAM and EclLAM from sputum, stool, urine; CRISPR-Cas from blood; stool PCR; QuantiFERON(R)-TB Gold Plus.
Locations (1)
Division of Infectious Diseases, I. Department of Internal Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Hamburg, Germany