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Sputum-free Diagnostis of TB

NCT07125274 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-08-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Research Center Borstel

    lead OTHER

Principal Investigators

  • Christoph Lange, Prof. Dr. Dr. h.c. · Clinical Infectious Diseases, Research Center Borstel, Leibniz Lung Center

  • Marylyn Martina Addo, Prof. Dr. · Institute for Infection Research and Vaccine Development, University Medical Center Hamburg-Eppendorf

  • Stefan Schmiedel, Dr. med. · Division of Infectious Diseases, I. Department of Internal Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-06
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07125274 on ClinicalTrials.gov