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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

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
University Hospital Bonn
Coordinator of this site? Confirm its status
BonnGermanyNot yet recruiting
Research center Borstel
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BorstelGermanyRecruiting
University Hospital of Cologne
Coordinator of this site? Confirm its status
CologneGermanyRecruiting
University Hospital Frankfurt
Coordinator of this site? Confirm its status
FrankfurtGermanyNot yet recruiting
University Hospital Hamburg
Coordinator of this site? Confirm its status
HamburgGermanyRecruiting
University Hospital Heidelberg
Coordinator of this site? Confirm its status
HeidelbergGermanyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.