Studies Biomarkers in Adults Newly Diagnosed With Extrapulmonary Tuberculosis
Follows adults newly diagnosed with tuberculosis outside the lungs, using body fluid samples over treatment.
Plain-language title generated from the registry record
Registry title: A Multicentric Cohort and Biomarker Study for Improved Care of Patients with Extrapulmonary Tuberculosis
Key facts
- Where
- Bonn, Borstel, Cologne, Frankfurt, Hamburg, and Heidelberg, GermanySee the 6 sites
Where in Germany
- University Hospital BonnBonn, GermanyNot yet recruiting
- Research center BorstelBorstel, GermanyTaking people
- University Hospital of CologneCologne, GermanyTaking people
- University Hospital FrankfurtFrankfurt, GermanyNot yet recruiting
- University Hospital HamburgHamburg, GermanyTaking people
- University Hospital HeidelbergHeidelberg, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Cologne
- Trial code
- NCT06875336
- Record updated
- 13 March 2025
- Original description
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.Read full original descriptionShow less
A Multicentric Cohort and Biomarker Study for Improved Care of Patients with Extrapulmonary Tuberculosis
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.
Inclusion: 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.
Exclusion: 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.