An observational study in Tuberculosis, sponsored by Research Center Borstel. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-15.
Sponsored by Research Center Borstel · Observational
The aim of this study is to identify new biomarkers that enable reliable, non-invasive diagnosis of tuberculosis (TB), including in patients who are unable to produce sputum. The study analyzes biomaterials (blood, urine, stool, sputum) collected from patients with suspected TB. Various diagnostic methods are applied to assess the feasibility of individual and combined biomarker tests.
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.
1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.
This study's planned enrollment of 100 is below the median of 253 across 317 observational studies indexed under Tuberculosis.
Browse Tuberculosis studies →Research Center Borstel is the lead sponsor of 16 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients > 18 years of age, including women of childbearing potential with or without contraception. Only adult patients capable of giving informed consent will be included; obtaining consent from legal guardians is not planned.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic Test: Biomarker-guided diagnostic tests
Diagnostic Test: 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.
Feasibility of biomarker-guided diagnosis of TB - mRNA signatures
Assessment of the feasibility of tuberculosis (TB) diagnostics based on mRNA signatures.
Time frame: From enrollment to the end of the first week of treatment
Feasibility of biomarker-guided diagnosis of TB - cellular immunology
Assessment of the feasibility of tuberculosis (TB) diagnostics based on cellular immunology.
Time frame: From enrollment to the end of the first week of treatment
Feasibility of biomarker-guided diagnosis of TB - PATHFAST-LAM
Assessment of the feasibility of tuberculosis (TB) diagnostics based on PATHFAST-LAM.
Time frame: From enrollment to the end of the first week of treatment
Feasibility of biomarker-guided diagnosis of TB - EclLAM
Assessment of the feasibility of tuberculosis (TB) diagnostics based on EclLAM assays.
Time frame: From enrollment to the end of the first week of treatment
Feasibility of biomarker-guided diagnosis of TB - cell-free Mycobacterium tuberculosis DNA
Assessment of the feasibility of tuberculosis (TB) diagnostics based on cell-free Mycobacterium tuberculosis DNA.
Time frame: From enrollment to the end of the first week of treatment
Feasibility of biomarker-guided diagnosis of TB - MBLA
Assessment of the feasibility of tuberculosis (TB) diagnostics based on Mycobacterial Load Assay (MBLA).
Time frame: From enrollment to the end of the first week of treatment
Feasibility of biomarker-guided diagnosis of TB - stool PCR
Assessment of the feasibility of tuberculosis (TB) diagnostics based on stool PCR testing.
Time frame: From enrollment to the end of the first week of treatment
Feasibility of biomarker-guided diagnosis of TB - composit
Assessment of the feasibility of tuberculosis (TB) diagnostics based on a combination of mRNA signatures, cellular immunology, PATHFAST-LAM and EclLAM assays, cell-free Mycobacterium tuberculosis DNA analysis, MBLA, stool PCR testing, and QuantiFERON®-TB Gold Plus testing.
Time frame: From enrollment to the end of the first week of treatment
Exploratory Analysis of Biomarker Profiles and Their Clinical Associations
Degree of correlation between the different biomarkers.
Time frame: From enrollment to the end of the first week of treatment.
Exploratory Analysis of Biomarker Profiles and Their Clinical Associations
Qualitative and quantitative characterization of differences in biomarker profiles between pulmonary and extrapulmonary tuberculosis.
Time frame: From enrollment to the end of the first week of treatment.
Exploratory Analysis of Biomarker Profiles and Their Clinical Associations
Qualitative and quantitative characterization of sex-specific differences in biomarker expression patterns.
Time frame: From enrollment to the end of the first week of treatment.
Exploratory Analysis of Biomarker Profiles and Their Clinical Associations
Degree of correlation between biomarkers and disease severity, as well as their potential prognostic value.
Time frame: From enrollment to the end of the first week of treatment.
Plan to share: Yes — all IPD collected throughout the trial
Supporting information: Study protocol, Informed consent form
Time frame: Starting mid 2027
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Dec 2026, 18 months after the start.
Of 122 non-industry observational studies under Tuberculosis, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 76. This study's planned 18 months is below that.
Counting every sponsor, half of 134 studies reached it within 36 months; a quarter within 21 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Research Center Borstel