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.
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
1. Age <18 years 2. Patient with any social or logistical condition which, as anticipated by the investigator, may interfere with the conduct of the study, such as incapacity to well understand the study content and procedure (in case of any language barriers, a translator may be involved), not willing to collaborate, or anticipated inability to finish study due to physical weakness 3. Dependencies towards the study team (e.g. family members, employees of the same department) 4. Pregnant women 5. Patient in custodianship or guardianship 6. Leading pulmonary manifestation 7. Solitary CNS tuberculosis Patients may take part in other clinical studies and trials, as long as there is no conflict with the inclusion or exclusion criteria of the mEX-TB study and the protocol of the other study or trial does not conflict with the means of data and sample collection and publication of this protocol.
Participants are regular patients at the University Hospital of Cologne
Cohort
Prospective
biomarker analysis
Diagnostic testPAXgene 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.
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.
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.
Evaluation of clinical data to identify risk factors for dissemination of the disease (limited vs severe disease)
The clinical picture of extrapulmonary tuberculosis is very heterogeneous and it is still not clear which factors lead to the development of lymph node tuberculosis in some patients and disseminated disease in others. Using the clinical cohort, the disease pattern will be described more precisely.
Influence of former refugee experience on the spread of the disease
The clinical picture of extrapulmonary tuberculosis is very heterogeneous and it is still not clear which factors lead to the development of lymph node tuberculosis in some patients and disseminated disease in others. Using the clinical cohort, the disease pattern will be described more precisely.
Proportion and description of paradoxical reaction and identifying biomarkers predicting occurrence of paradoxical reactions (e.g. IP-10)
Risk factors for the occurrence of paradoxical reactions will be identified by analyzing clinical data.
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University of Cologne
Lead sponsor
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
