NCT06875336Recruiting
A Multicentric Cohort and Biomarker Study for Improved Care of Patients with Extrapulmonary Tuberculosis
Source: ClinicalTrials.gov · Last updated 13 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 12 May 2023
- Start date
- 6 Mar 2023
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- University of Cologne
- Diseases
- Tuberculosis
- NCT number
- NCT06875336
What you commit to
- Study type: Observational
- Planned participants: 150
- From 6 Mar 2023 to the primary completion date, 31 Dec 2025
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Bonn Coordinator of this site? Confirm its status | Bonn | Germany | Not yet recruiting |
| Research center Borstel Coordinator of this site? Confirm its status | Borstel | Germany | Recruiting |
| University Hospital of Cologne Coordinator of this site? Confirm its status | Cologne | Germany | Recruiting |
| University Hospital Frankfurt Coordinator of this site? Confirm its status | Frankfurt | Germany | Not yet recruiting |
| University Hospital Hamburg Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| University Hospital Heidelberg Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.