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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Suspected pulmonary or extrapulmonary tuberculosis, or confirmed pulmonary or extrapulmonary tuberculosis with less than 7 days of anti-tuberculosis treatment, OR other pulmonary infection (control group).
* Age ≥ 18 years
* Ability to provide informed consent
* Willingness to participate in the study
Exclusion Criteria:
* Lack of ability to provide informed consent
* Age \< 18 years
* Pregnancy
Primary outcome measure(s)
Feasibility of biomarker-guided diagnosis of TB - mRNA signatures — From enrollment to the end of the first week of treatment Assessment of the feasibility of tuberculosis (TB) diagnostics based on mRNA signatures.
Feasibility of biomarker-guided diagnosis of TB - cellular immunology — From enrollment to the end of the first week of treatment Assessment of the feasibility of tuberculosis (TB) diagnostics based on cellular immunology.
Feasibility of biomarker-guided diagnosis of TB - PATHFAST-LAM — From enrollment to the end of the first week of treatment Assessment of the feasibility of tuberculosis (TB) diagnostics based on PATHFAST-LAM.
Feasibility of biomarker-guided diagnosis of TB - EclLAM — From enrollment to the end of the first week of treatment Assessment of the feasibility of tuberculosis (TB) diagnostics based on EclLAM assays.
Feasibility of biomarker-guided diagnosis of TB - cell-free Mycobacterium tuberculosis DNA — From enrollment to the end of the first week of treatment Assessment of the feasibility of tuberculosis (TB) diagnostics based on cell-free Mycobacterium tuberculosis DNA.
Feasibility of biomarker-guided diagnosis of TB - MBLA — From enrollment to the end of the first week of treatment Assessment of the feasibility of tuberculosis (TB) diagnostics based on Mycobacterial Load Assay (MBLA).
Feasibility of biomarker-guided diagnosis of TB - stool PCR — From enrollment to the end of the first week of treatment Assessment of the feasibility of tuberculosis (TB) diagnostics based on stool PCR testing.
Feasibility of biomarker-guided diagnosis of TB - composit — From enrollment to the end of the first week of treatment Assessment of the feasibility of tuberculosis (TB) diagnostics based on a combination of mRNA signatures, cellular immunology, PATHFAST-LAM and EclLAM assays, cell-free Mycobacterium tuberculosis DNA analysis, MBLA, stool PCR testing, and QuantiFERON®-TB Gold Plus testing.
Trial sites (1)
Facility
City
Region
Status
Division of Infectious Diseases, I. Department of Internal Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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