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RECRUITING
NCT06875336

A Multicentric Cohort and Biomarker Study for Improved Care of Patients with Extrapulmonary Tuberculosis

Sponsor: University of Cologne

View on ClinicalTrials.gov

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

Interventions

DIAGNOSTIC_TEST

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