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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05048381
Other study ID # 2021-01810; am21Eckstein2
Secondary ID
Status Withdrawn
Phase
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
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