MedTrace Logo

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

NCT06875336 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2025-03-13

No results posted yet for this study

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.

Conditions

  • Extrapulmonary Tuberculosis

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.

Sponsors & Collaborators

  • University Hospital, Bonn

    collaborator OTHER

  • Research Center Borstel

    collaborator OTHER

  • Johann Wolfgang Goethe University Hospital

    collaborator OTHER

  • Universitätsklinikum Hamburg-Eppendorf

    collaborator OTHER

  • University Hospital Heidelberg

    collaborator OTHER

  • Helmholtz Zentrum München

    collaborator INDUSTRY

  • University Hospital of Cologne

    collaborator OTHER

  • University of Cologne

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-06
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06875336 on ClinicalTrials.gov