Clinical Trial

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

Study acronym: mEX-TB

Recruiting

Record status

This record was last updated March 13, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

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.

Trial Details

NCT Number	NCT06875336
Lead Sponsor	University of Cologne Collaborators: University Hospital, Bonn, Research Center Borstel, Johann Wolfgang Goethe University Hospital, Universitätsklinikum Hamburg-Eppendorf, University Hospital Heidelberg, Helmholtz Zentrum München, University Hospital of Cologne
Conditions	Extrapulmonary Tuberculosis
Enrollment	150 participants
Start Date	2023-03-06
Primary Completion	2025-12-31 (estimated)
Study Completion	2025-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-03-13