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

• Sponsor: University Hospital, Basel, Switzerland (Other)
• Overall Status: Suspended
• CT.gov ID: NCT05048381
• Collaborator: Fachhochschule Nordwestschweiz (Other)
• Enrollment: 35
• Location: 1
• Anticipated Duration (Months): 12.8
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Active Tuberculosis	Diagnostic Test: Next Generation Sequencing

Study Design

• Study Type: Observational
• Anticipated Enrollment: 35 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: miRNA in Sweat, a Novel Digital Biomarker for Detection of Active Tuberculosis
• Actual Study Start Date: Sep 6, 2021
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Outcome Measures

Primary Outcome Measures

1. Detection of miRNA (non-coding ribonucleic acid) in sweat [Sweat samples taken at baseline]

   Analysis of sweat protein markers in patients with active tuberculosis

2. Detection of miRNA (non-coding ribonucleic acid) in blood [Blood samples taken at baseline]

   Analysis of blood protein markers in patients with active tuberculosis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chief Medical Information Office (CMIO), University Hospital Basel	Basel		Switzerland	4031

Sponsors and Collaborators

• University Hospital, Basel, Switzerland
• Fachhochschule Nordwestschweiz

Investigators

• Principal Investigator: Jens Eckstein, Prof. Dr. med., Chief Medical Information Office (CMIO), University Hospital Basel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Basel, Switzerland
• ClinicalTrials.gov Identifier: NCT05048381
• Other Study ID Numbers: 2021-01810; am21Eckstein2
• First Posted: Sep 17, 2021
• Last Update Posted: Aug 11, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Basel, Switzerland: miRNA; Mycobacterium Tuberculosis; Next Generation Sequencing
• Additional relevant MeSH terms: Tuberculosis

Study Results

No Results Posted as of Aug 11, 2022