miRNA in Sweat, a Novel Digital Biomarker for Detection of Active Tuberculosis (TB)

miRNA in Sweat, a Novel Digital Biomarker for Detection of Active Tuberculosis

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05048381

Enrollment

Registered

2021-09-17

Start date

2021-09-06

Completion date

2022-10-31

Last updated

2023-11-01

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

Conditions

Active Tuberculosis

Keywords

miRNA, Mycobacterium Tuberculosis, Next Generation Sequencing

Brief summary

The detection of miRNA (non-coding ribonucleic acid) in the blood in the context of active tuberculosis is an innovative approach to the detection of new disease-specific biomarkers. The primary goal of this analysis is to define, for the first time, an miRNA fingerprint for tuberculosis in sweat. Samples that were collected as part of the Sweatb Study (NCT03667742) project are examined for the occurrence of disease-specific, non-coding miRNAs to define new biomarkers in the sweat. These biomarkers can be detected non-invasively and will help in the detection of patients with active tuberculosis.

Interventions

DIAGNOSTIC_TESTNext Generation Sequencing

Next Generation Sequencing of sweat and whole blood samples for non-coding miRNAs to define biomarkers that enable to differentiate between patients with active tuberculosis, a differential diagnostic disease and healthy individuals.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult patients * Ability to understand the purpose of the study, provide signed and dated informed consent by patient or his/her legal representative * In-patients with acute tuberculosis, suspected tuberculosis or other pulmonary diseases (pneumonia, Bronchitis, COPD) Inclusion criteria Healthy Donors: * negative for Quantiferon- TB Gold Plus Test or ELISpot

Exclusion criteria

* Written rejection of the consent for the further use of the data

Design outcomes

Primary

Measure	Time frame	Description
Detection of miRNA (non-coding ribonucleic acid) in sweat	Sweat samples taken at baseline	Analysis of sweat protein markers in patients with active tuberculosis
Detection of miRNA (non-coding ribonucleic acid) in blood	Blood samples taken at baseline	Analysis of blood protein markers in patients with active tuberculosis

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026