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

NCT05048381 | Withdrawn

• 1 other identifier: 2021-01810; am21Eckstein2
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Active Tuberculosis

Keywords

miRNA; Mycobacterium Tuberculosis; Next Generation Sequencing

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

Next Generation Sequencing DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All participants in the Sweatb study (NCT03667742)

You may qualify if:

• 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

You may not qualify if:

• Written rejection of the consent for the further use of the data

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Fachhochschule Nordwestschweiz: collaborator

MeSH Terms

Conditions

Latent Tuberculosis

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Study Officials

• Jens Eckstein, Prof. Dr. med.

  Chief Medical Information Office (CMIO), University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 17, 2021
• Study Start: September 6, 2021
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: November 1, 2023

Record last verified: 2023-10