Actively Recruiting
A Multicentric Cohort and Biomarker Study for Improved Care of Patients with Extrapulmonary Tuberculosis
Led by University of Cologne · Updated on 2025-03-13
150
Participants Needed
6
Research Sites
147 weeks
Total Duration
On this page
Sponsors
U
University of Cologne
Lead Sponsor
U
University Hospital, Bonn
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Multicentric Cohort and Biomarker Study for Improved Care of Patients with Extrapulmonary Tuberculosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of extrapulmonary tuberculosis confirmed by PCR, culture, or clinical diagnosis based on exposure and findings
- Extrapulmonary TB affecting sites such as pleura, lymph nodes, bones and joints, larynx, pericardium, parotid gland, abdomen, kidneys, genitourinary tract, or disseminated TB
- If both pulmonary and extrapulmonary TB are present, the main disease must be extrapulmonary
- Ability to provide written informed consent before joining the study
You will not qualify if you...
- Age under 18 years
- Social or logistical conditions that may prevent study participation or understanding, including language barriers without translator
- Unwillingness to collaborate or anticipated inability to complete the study due to physical weakness
- Family or employee dependencies on the study team
- Pregnancy
- Legal custodianship or guardianship
- Main tuberculosis manifestation is pulmonary
- Solitary central nervous system tuberculosis
- Participation in conflicting clinical studies or trials that interfere with data or sample collection for this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
University Hospital Bonn
Bonn, Germany, 53127
Not Yet Recruiting
2
Research Center Borstel
Borstel, Germany, 23845
Actively Recruiting
3
University Hospital of Cologne
Cologne, Germany, 50937
Actively Recruiting
4
University Hospital Frankfurt
Frankfurt, Germany, 60590 Frankfurt
Not Yet Recruiting
5
University Hospital Hamburg
Hamburg, Germany, 20251 Hamburg
Actively Recruiting
6
University Hospital Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
Research Team
I
Isabelle Suarez, Dr
CONTACT
A
Angela Klingmüller, Dr
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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