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

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.

Study Overview

• Status: Withdrawn
• Conditions: Active Tuberculosis
• Intervention / Treatment: Diagnostic test: Next Generation Sequencing

• Study Type: Observational

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Chief Medical Information Office (CMIO), University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All participants in the Sweatb study (NCT03667742)

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Fachhochschule Nordwestschweiz
• Investigators: Principal Investigator: Jens Eckstein, Prof. Dr. med., Chief Medical Information Office (CMIO), University Hospital Basel

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2021
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: September 8, 2021
• First Submitted That Met QC Criteria: September 8, 2021
• First Posted (Actual): September 17, 2021

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: miRNA; Next Generation Sequencing; Mycobacterium Tuberculosis
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: 2021-01810; am21Eckstein2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No