Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2025-06-06
2026-12-31
Brief Summary
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Participating patients will provide biomaterial samples (blood, urine, stool, sputum) once. No additional examinations or invasive procedures will be performed. Routine diagnostic procedures remain unaffected.
This is a single-center, prospective observational study. Patients are enrolled as part of their clinical care at the University Medical Center Hamburg-Eppendorf.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with suspected TB
Biomarker-guided diagnostic tests
mRNA-Signature from blood; immunophenotyping from blood; MBLA from sputum, PATHFAST-LAM and EclLAM from sputum, stool, urine; CRISPR-Cas from blood; stool PCR; QuantiFERON(R)-TB Gold Plus.
Other pulmonary infections (control group)
Biomarker-guided diagnostic tests
mRNA-Signature from blood; immunophenotyping from blood; MBLA from sputum, PATHFAST-LAM and EclLAM from sputum, stool, urine; CRISPR-Cas from blood; stool PCR; QuantiFERON(R)-TB Gold Plus.
Interventions
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Biomarker-guided diagnostic tests
mRNA-Signature from blood; immunophenotyping from blood; MBLA from sputum, PATHFAST-LAM and EclLAM from sputum, stool, urine; CRISPR-Cas from blood; stool PCR; QuantiFERON(R)-TB Gold Plus.
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
* Ability to provide informed consent
* Willingness to participate in the study
Exclusion Criteria
* Age \< 18 years
* Pregnancy
18 Years
ALL
No
Sponsors
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Research Center Borstel
OTHER
Responsible Party
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Thomas Theo Brehm
Dr. med.
Principal Investigators
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Christoph Lange, Prof. Dr. Dr. h.c.
Role: STUDY_CHAIR
Clinical Infectious Diseases, Research Center Borstel, Leibniz Lung Center
Marylyn Martina Addo, Prof. Dr.
Role: STUDY_CHAIR
Institute for Infection Research and Vaccine Development, University Medical Center Hamburg-Eppendorf
Stefan Schmiedel, Dr. med.
Role: STUDY_CHAIR
Division of Infectious Diseases, I. Department of Internal Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Locations
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Division of Infectious Diseases, I. Department of Internal Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Hamburg, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TBDiagnostics2025-101457-BO-ff
Identifier Type: -
Identifier Source: org_study_id
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