A multicentric cohort and biomarker study for improved care of patients with extrapulmonary tuberculosis (mEX-TB)
The prospective, multicenter study, "mEX-TB," aims to improve care for patients with extrapulmonary tuberculosis (EPTB). To this end, the study will identify biomarkers to detect risk factors for developing EPTB and enable biomarker-based diagnosis and treatment of patients in the future. To achieve this, clinical data and biosamples from EPTB patients will be collected at six sites, analyzed, and evaluated in a central biobank. This project's findings are expected to improve EPTB patient care in Germany and countries with high tuberculosis incidence and contribute to the World Health Organization's goal of eliminating tuberculosis by 2050.
Of the approximately 10 million tuberculosis cases detected each year, about one-quarter affect organs outside the lungs. These cases are referred to as extrapulmonary tuberculosis (EPTB). Despite the significant number of patients and the challenges that EPTB poses for diagnosis and treatment, the scientific community has largely overlooked it. The vast majority of clinical studies in this field have focused on pulmonary TB.
Given the high prevalence and increasing incidence of EPTB in several countries, there is a medical need to better understand and treat this disease. Under the leadership of DZIF scientists Isabelle Suárez and Jan Rybniker, a new multicenter prospective study is being conducted at the DZIF. The study's findings are expected to improve patient care. The EX-TB pilot study, which has been conducted at the DZIF since 2018, is now being carried out as a multicenter study (mEX-TB), with the University Hospital Cologne serving as the lead institution.
This three-year study aims to identify EPTB biomarkers to determine risk factors for developing EPTB, and enable the biomarker-based diagnosis and treatment of EPTB patients.
Adult patients newly diagnosed with EPTB will be enrolled prospectively in the study at six sites: Bonn, Borstel, Frankfurt, Hamburg, Heidelberg, and Cologne. Clinical data will be collected from each patient using standardized questionnaires throughout the treatment period. Additionally, blood samples will be collected, stored, analyzed, and evaluated in a central biobank. During the course of treatment, the biomarkers of the EPTB patients will be analyzed and correlated with the clinical data. A healthy control group will also be included and will primarily serve as a technical control for complex laboratory procedures, such as RNA sequencing and T-cell-based assays.
The project's findings will improve care for EPTB patients in Germany and high-incidence TB countries, contributing to the World Health Organization's goal of eliminating TB by 2050.
