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

NCT06875336 | Recruiting

• 1 other identifier: TTU 02.913_00
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

extrapulmonary tuberculosis; biomarker; cohort study

Outcome Measures

Primary Outcomes (2)

• Evaluation of blood biomarkers as diagnostic tools for EPTB (gene expression via RNA-seq and T-cell response based)

  There is limited research on extrapumonary tuberculosis. In particular, it is difficult to establish the diagnosis. Therefore, one aim of this study is to investigate biomarkers (gene expression via RNA-seq and T-cell response based) that have been shown to be effective for pumonal tuberculosis also for extrapulmonary tuberculosis.

  two years

• Evaluation of blood biomarkers to predict treatment response or failure, and cure in EPTB

  There is limited research on extrapumonary tuberculosis. In particular, treatment duration is difficult to estimate. Therefore, one aim of this study is to investigate biomarkers (gene expression via RNA-seq and T-cell response based) that have been shown to be useful for pulmonary tuberculosis also for extrapulmonary tuberculosis.

  two years

Secondary Outcomes (3)

• Evaluation of clinical data to identify risk factors for dissemination of the disease (limited vs severe disease)

  two years

• Influence of former refugee experience on the spread of the disease

  two years

• Proportion and description of paradoxical reaction and identifying biomarkers predicting occurrence of paradoxical reactions (e.g. IP-10)

  two years

Study Arms (1)

Patients with extrapulmonary tuberculosis

During the visits routine clinical and laboratory parameters (assessment of symptoms e.g. pain, weight gain, blood count, liver enzymes, renal parameters, vitamin D levels, CRP etc.), radiographic imaging (ultrasound, CT scan or MRI) and drug specific parameters (dose, interval, adverse events) are documented. Moreover, 3 sputum specimens (on 3 different days) and 1 urine specimen are collected initially for microscopy, PCR and culture through in-house microbiology departments. A paper case record form (CRF) will be used to collect patient data, which will be then transferred to an electronic database by local study personnel. At each time-point a series of additional specimens, consisting of serum, urine, heparin blood, and PAXgene blood for RNA will be collected and stored. 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.

Diagnostic Test: biomarker analysis

Interventions

biomarker analysis DIAGNOSTIC_TEST

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.

Patients with extrapulmonary tuberculosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants are regular patients at the University Hospital of Cologne

You may qualify if:

• 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

Sponsors & Collaborators

• University of Cologne: lead
• University Hospital, Bonn: collaborator
• Research Center Borstel: collaborator
• Johann Wolfgang Goethe University Hospital: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• University Hospital Heidelberg: collaborator
• Helmholtz Zentrum München: collaborator
• University Hospital of Cologne: collaborator

Study Sites (6)

University Hospital Bonn

Bonn, 53127, Germany

NOT YET RECRUITING

Research Center Borstel

Borstel, 23845, Germany

RECRUITING

University Hospital of Cologne

Cologne, 50937, Germany

RECRUITING

University Hospital Frankfurt

Frankfurt, 60590 Frankfurt, Germany

NOT YET RECRUITING

University Hospital Hamburg

Hamburg, 20251 Hamburg, Germany

RECRUITING

University Hospital Heidelberg

Heidelberg, 69120, Germany

RECRUITING

Related Publications (17)

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Biospecimen

Retention: SAMPLES WITH DNA

serum urine heparin blood PAXgene blood sputum

MeSH Terms

Conditions

Tuberculosis, Extrapulmonary

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Central Study Contacts

Isabelle Suarez, Dr

CONTACT

+49 (221) 478-39680; isabelle.suarez@uk-koeln.de

Angela Klingmüller, Dr

CONTACT

angela.klingmueller@uk-koeln.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: March 13, 2025
• Study Start: March 6, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

DE (6)