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A Multicentric Cohort and Biomarker Study for Improved Care of Patients with Extrapulmonary Tuberculosis
Sponsor: University of Cologne
Summary
This is a prospective, multicenter, observational study (mEX-TB study) of patients with extrapulmonary tuberculosis (EPTB). Adult patients newly diagnosed with EPTB will prospectively be enrolled into the study. Clinical data will be collected using standardized questionnaires over the whole treatment period for each individual. Additionally, body fluids (blood, urine) will be collected and stored in a central biobank. Biomarkers in EPTB patients will be analyzed during the course of therapy and correlated with clinical data. In addition, a healthy control group will be added, to be used primarily as technical controls for complex laboratory procedures such as RNA-seq and T-cell based assays.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
150
Start Date
2023-03-06
Completion Date
2025-12-31
Last Updated
2025-03-13
Healthy Volunteers
No
Conditions
Interventions
biomarker analysis
PAXgene blood for RNA will be collected and stored. Results from these additional examinations are not included in the treatment monitoring of the patient concerned. If M. tuberculosis can be cultivated, strains will be stored for genotyping and whole genome sequencing. Serum biomarkers will be tested using commercially available kits. In addition, TAM-TB assays will be performed from samples stored at each time-point. For this purpose, PBMCs will be collected and frozen using well-established protocols.
Locations (6)
University Hospital Bonn
Bonn, Germany
Research Center Borstel
Borstel, Germany
University Hospital of Cologne
Cologne, Germany
University Hospital Frankfurt
Frankfurt, Germany
University Hospital Hamburg
Hamburg, Germany
University Hospital Heidelberg
Heidelberg, Germany