Borstel

Researchers are conducting a multicenter observational study called the mEX-TB study to better understand extrapulmonary tuberculosis (EPTB) in adults. The study aims to improve clinical management by developing specific blood-based biomarkers for diagnosing EPTB and predicting treatment responses. This is important because EPTB cases have been increasing in Europe, and current diagnostic tools used for pulmonary TB are often not applicable for EPTB. The study involves patients newly diagnosed with EPTB and also includes groups of pulmonary TB patients and healthy controls for comparison. Patients will be enrolled and followed over their treatment period, with clinical data collected through standardized questionnaires at multiple time points: diagnosis, 4 weeks, 3 months, 6 months after treatment start, and 3 months post-treatment. Blood and urine samples will be collected and stored in a central biobank. Biomarker analyses include gene expression profiling and T-cell based assays from blood samples. The study has different patient strata depending on the completeness of sample collection. Participants will undergo evaluations including clinical assessments, imaging, and laboratory tests throughout the study. Researchers will monitor treatment responses using clinical signs such as symptom improvement, weight gain, and regression of local disease findings. Blood biomarkers will be correlated with these clinical outcomes to assess their value in diagnosing EPTB and predicting treatment success or failure over a two-year period. Data collection and biomaterial storage will be carefully managed to support these objectives.