Analysis of Biomarkers of Inflammation as Diagnostic Tools for Mycobacterial Diseases

Analysis of Biomarkers of Inflammation as Diagnostic Tools for Mycobacterial Diseases - TRACE-TB

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00039040

Enrollment

Registered

2026-01-26

Start date

2026-01-09

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

A15-A19 D86.0 D86.2 J70.2 J70.3 M30.1 M31.3 J84.9 J70.4

Interventions

Group 1: What is done within the scope of this study? This prospective, non-interventional observational study involves the collection of venous blood samples from adult participants across five diagn

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Participants must meet all of the following criteria to be eligible for inclusion in the study: • Age 18 years or older • Able and willing to provide written informed consent • Belong to one of the following groups: o Pulmonary tuberculosis (PTB) o Extrapulmonary tuberculosis (EPTB) o Non-tuberculous mycobacterial pulmonary disease (NTM-PD) o Non-infectious inflammatory lung disease o Controls

Exclusion criteria

Exclusion criteria: Participants meeting any of the following criteria will be excluded from the study: • Under the age of 18 • Unable or unwilling to provide informed consent

Design outcomes

Primary

Measure	Time frame
The primary outcome of the TRACE-TB study is the differential expression of serum biomarkers among the five study groups. Specific biomarkers of interest include MMP and TIMP. The main analysis metric will be absolute concentration values and relative changes over time, depending on the group. Data will be aggregated using median and interquartile range for continuous variables and proportion for categorical comparisons.	—

Measure

Time frame

The primary outcome of the TRACE-TB study is the differential expression of serum biomarkers among the five study groups. Specific biomarkers of interest include MMP and TIMP. The main analysis metric will be absolute concentration values and relative changes over time, depending on the group. Data will be aggregated using median and interquartile range for continuous variables and proportion for categorical comparisons.

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Secondary

Measure	Time frame
Secondary outcomes include within-group changes in biomarker levels from baseline to follow-up (for Groups I–III), and the discriminatory potential of specific biomarker patterns to differentiate between TB, NTM, inflammatory lung disease, and healthy controls for the following biomarkers: A1AGP1, CD4-cell activation status and if available other inflammatory markers such as CRP, PCT, fibrinogen, haptoglobin, serum transferrin and markers associated with lipid metabolism (e.g., lipoprotein A). The clinical relevance of these outcomes lies in the potential to identify fast, less invasive markers for improved diagnosis and monitoring of TB and related conditions.	—

Measure

Time frame

Secondary outcomes include within-group changes in biomarker levels from baseline to follow-up (for Groups I–III), and the discriminatory potential of specific biomarker patterns to differentiate between TB, NTM, inflammatory lung disease, and healthy controls for the following biomarkers: A1AGP1, CD4-cell activation status and if available other inflammatory markers such as CRP, PCT, fibrinogen, haptoglobin, serum transferrin and markers associated with lipid metabolism (e.g., lipoprotein A). The clinical relevance of these outcomes lies in the potential to identify fast, less invasive markers for improved diagnosis and monitoring of TB and related conditions.

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Countries

Germany

Contacts

Public ContactRaja Idris

Universitätsklinikum Frankfurt, Medizinische Klinik 2, Infektiologie

Raja.Idris@unimedizin-ffm.de069 6301 86540

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026