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

NCT ID: NCT05048381

Last Updated: 2023-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-06

Study Completion Date

2022-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Active Tuberculosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Next 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)


* negative for Quantiferon- TB Gold Plus Test or ELISpot

Exclusion Criteria

* Written rejection of the consent for the further use of the data
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fachhochschule Nordwestschweiz

OTHER

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jens Eckstein, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Chief Medical Information Office (CMIO), University Hospital Basel

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021-01810; am21Eckstein2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Innovation in Tuberculosis
NCT04002869 UNKNOWN
Host Blood RNA Signatures for Diagnosis of TB
NCT05542511 ACTIVE_NOT_RECRUITING