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RecruitingNCT06875336

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

Sponsor

University of Cologne

Enrollment

150 participants

Start Date

Mar 6, 2023

Study Type

OBSERVATIONAL

Conditions

Extrapulmonary Tuberculosis

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria18

  • Age ≥ 18 years
  • Isolation of Mycobacterium tuberculosis complex from a bodily secretion or tissue by
  • PCR
  • culture or a presumptive clinical diagnosis based on epidemiologic exposure in combination with physical findings, radiographic findings and/or histopathology
  • Patients with extrapulmonary TB
  • pleura
  • lymph nodes
  • bones and joints
  • larynx
  • pericardial
  • parotid gland
  • abdominal sites
  • kidneys
  • genitourinary tract
  • disseminated (miliary) TB
  • other than pulmonary TB
  • In the case of pulmonary and extrapulmonary involvement, the leading manifestation, clinically and radiographically, must be extrapulmonary.
  • Written informed consent provided prior to inclusion

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Interventions

DIAGNOSTIC_TESTbiomarker 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

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NCT06875336