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

Active Tuberculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05048381
• Other study ID #: 2021-01810; am21Eckstein2
• Status: Withdrawn
• Start date: September 6, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: October 2023
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Active Tuberculosis
• Tuberculosis

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Fachhochschule Nordwestschweiz

Outcome

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