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

Withdrawn
Conditions
Active Tuberculosis
Registration Number
NCT05048381
Lead Sponsor
University Hospital, Basel, Switzerland
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Detection of miRNA (non-coding ribonucleic acid) in bloodBlood samples taken at baseline

Analysis of blood protein markers in patients with active tuberculosis

Detection of miRNA (non-coding ribonucleic acid) in sweatSweat samples taken at baseline

Analysis of sweat protein markers in patients with active tuberculosis

Secondary Outcome Measures
NameTimeMethod
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