A Multicentric Cohort and Biomarker Study for Improved Care of Patients with Extrapulmonary Tuberculosis
Recruiting now
Conditions studied: Extrapulmonary Tuberculosis
In brief
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.
Key facts
- Study ID
- NCT06875336
- Run by
- University of Cologne
- People needed
- 150
- Starts
- 2023-03-06
- Expected to finish
- 2025-12-31
- Last updated by the study team
- 2025-03-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
- 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
You may not qualify if…
- 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.
Where it is running
- Research Center Borstel — Borstel, Germany (enrolling)
- University Hospital of Cologne — Cologne, Germany (enrolling)
- University Hospital Hamburg — Hamburg, Germany (enrolling)
- University Hospital Heidelberg — Heidelberg, Germany (enrolling)
- University Hospital Bonn — Bonn, Germany
- University Hospital Frankfurt — Frankfurt, Germany
Full record on ClinicalTrials.gov
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