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

October 30, 2023 updated by: University Hospital, Basel, Switzerland

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Withdrawn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

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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