Liver DiseasesNCT04341012
Breath Analysis Based Disease Biomarkers
An observational study of Liver Diseases and Liver Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of the study is to develop a clinical test based on breath analysis that can be used for disease diagnosis or prognosis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Liver Diseases, Liver Cancer, COVID19
- What is being tested?
- Collection of breath sample
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2019to 3 Sep 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects who are undergoing evaluation and obtaining clinical care at Mayo Clinic in Florida will be enrolled
Who may be able to join
- Able to provide informed consent
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Breath Analysis Test for Disease Diagnosis and Prognosis
The purpose of the study is to develop a clinical test based on breath analysis that can be used for disease diagnosis or prognosis.
Read the detailed description
The study will seek to collect and analyze breath samples from a broad range of patients to develop reference ranges and to refine the testing methods. Protocols for breath sample collection and algorithms for analysis will be developed. Samples will be collected from normal volunteers, persons with documented liver disease, organ transplant or with known COVID-19 test results.
- Conditions
- Liver Diseases, Liver Cancer, COVID19
- Being tested
- Collection of breath sample
- Medical subject headings
- Liver Diseases, Liver Neoplasms, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of breath sampleDiagnostic test
Analysis of volatile organic compounds in breath
| Study group | Role | What they receive |
|---|---|---|
| Normal | No known medical conditions Receives: Diagnostic Test: Collection of breath sample | |
| Liver Cirrhosis | Clinically diagnosed with cirrhosis Receives: Diagnostic Test: Collection of breath sample | |
| COVID-19 tested | Persons with known test results for COVID-19 RNA Receives: Diagnostic Test: Collection of breath sample | |
| Other | Persons with other medical diagnosis, no known liver disease, negative for COVID-19 Receives: Diagnostic Test: Collection of breath sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breath Volatile Organic Compound Profiles
Detection of profiles of volatile organic compounds present in exhaled breath. The values in the table represent the number of participants from whom a volatile organic compound profile was able to be detected.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start10 Sep 2019
- Primary completion3 Sep 2021
- Study completion3 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tushar Patel, Mayo Clinic
- Investigators
- Tushar Patel, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341012
- Sponsor's protocol ID
- 19-001971
- Status last verified
- Nov 2024
- First submitted
- 7 Apr 2020
- Last updated
- 26 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thomas JN, Roopkumar J, Patel T. Machine learning analysis of volatolomic profiles in breath can identify non-invasive biomarkers of liver disease: A pilot study. PLoS One. 2021 Nov 30;16(11):e0260098. doi: 10.1371/journal.pone.0260098. eCollection 2021.
PubMed 34847181
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Breath Analysis Test for Disease Diagnosis and Prognosis
- ClinicalTrials.gov ID
- NCT04341012
- Acronym / sponsor ID
- 19-001971
- Conditions
- Liver Diseases, Liver Cancer, COVID19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 3 Sep 2021 (actual)
- Study completion
- 3 Sep 2021 (actual)
- First posted
- 10 Apr 2020 (actual)
- Results
- Posted 15 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to develop a clinical test based on breath analysis that can be used for disease diagnosis or prognosis.
Detailed description
The study will seek to collect and analyze breath samples from a broad range of patients to develop reference ranges and to refine the testing methods. Protocols for breath sample collection and algorithms for analysis will be developed. Samples will be collected from normal volunteers, persons with documented liver disease, organ transplant or with known COVID-19 test results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal | – | Diagnostic Test: Collection of breath sampleNo known medical conditions |
| Liver Cirrhosis | – | Diagnostic Test: Collection of breath sampleClinically diagnosed with cirrhosis |
| COVID-19 tested | – | Diagnostic Test: Collection of breath samplePersons with known test results for COVID-19 RNA |
| Other | – | Diagnostic Test: Collection of breath samplePersons with other medical diagnosis, no known liver disease, negative for COVID-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who are undergoing evaluation and obtaining clinical care at Mayo Clinic in Florida will be enrolled
Key inclusion criteria (1 listed)
- Able to provide informed consent
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Collection of breath sampleAnalysis of volatile organic compounds in breath | Diagnostic test | COVID-19 tested, Liver Cirrhosis, Normal, Other |
Primary outcome
Breath Volatile Organic Compound Profiles
Time frame: 1 day
Detection of profiles of volatile organic compounds present in exhaled breath. The values in the table represent the number of participants from whom a volatile organic compound profile was able to be detected.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34847181Thomas JN, Roopkumar J, Patel T. Machine learning analysis of volatolomic profiles in breath can identify non-invasive biomarkers of liver disease: A pilot study. PLoS One. 2021 Nov 30;16(11):e0260098. doi: 10.1371/journal.pone.0260098. eCollection 2021.
- Individual participant dataSharing planned: No
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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.
Tushar Patel principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases and Liver Cancer, run by Mayo Clinic at 1 site in United States.
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 1 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: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 15 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Breath Volatile Organic Compound Profiles (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04341012, which also lists 1 linked publication.
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 26 Jan 2026.