Active TuberculosisNCT05048381
miRNA in Sweat, a Novel Digital Biomarker for Detection of Active Tuberculosis (TB)
An observational study of Active Tuberculosis, run by University Hospital, Basel, Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Active Tuberculosis
- What is being tested?
- Next Generation Sequencing
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 6 Sep 2021to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All participants in the Sweatb study (NCT03667742)
Who may be able to join
- 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
Who cannot join
- Written rejection of the consent for the further use of the data
About this study
Official title: miRNA in Sweat, a Novel Digital Biomarker for Detection of Active Tuberculosis
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
- Being tested
- Next Generation Sequencing
- Keywords
- miRNA, Mycobacterium Tuberculosis, Next Generation Sequencing
- Medical subject headings
- Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Next Generation SequencingDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of miRNA (non-coding ribonucleic acid) in sweat
Analysis of sweat protein markers in patients with active tuberculosis
Measured: Sweat samples taken at baseline
Detection of miRNA (non-coding ribonucleic acid) in blood
Analysis of blood protein markers in patients with active tuberculosis
Measured: Blood samples taken at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start6 Sep 2021
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Why it stopped: Technical challenges during lab sweat analysis lead to run out of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active TuberculosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Fachhochschule Nordwestschweiz
- Responsible party
- Sponsor
- Investigators
- Jens Eckstein, Prof. Dr. med., Principal investigator, Chief Medical Information Office (CMIO), University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048381
- Sponsor's protocol ID
- 2021-01810; am21Eckstein2
- Status last verified
- Oct 2023
- First submitted
- 8 Sep 2021
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- miRNA in Sweat, a Novel Digital Biomarker for Detection of Active Tuberculosis
- ClinicalTrials.gov ID
- NCT05048381
- Acronym / sponsor ID
- 2021-01810; am21Eckstein2
- Conditions
- Active Tuberculosis
- Keywords
- miRNA, Mycobacterium Tuberculosis, Next Generation Sequencing
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Technical challenges during lab sweat analysis lead to run out of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Fachhochschule Nordwestschweiz
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 17 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All participants in the Sweatb study (NCT03667742)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Written rejection of the consent for the further use of the data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Next Generation SequencingNext 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. | Diagnostic test | – |
Primary outcome
Detection of miRNA (non-coding ribonucleic acid) in sweat
Time frame: Sweat samples taken at baseline
Analysis of sweat protein markers in patients with active tuberculosis
Detection of miRNA (non-coding ribonucleic acid) in blood
Time frame: Blood samples taken at baseline
Analysis of blood protein markers in patients with active tuberculosis
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Eckstein, Prof. Dr. med. principal investigator
Chief Medical Information Office (CMIO), University Hospital Basel
Questions about this trial
What is this clinical trial studying?
An observational study of Active Tuberculosis, run by University Hospital, Basel, Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of miRNA (non-coding ribonucleic acid) in sweat (time frame: Sweat samples taken at baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.