An observational study in Liver Diseases, Liver Cancer and COVID19, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-26.
Sponsored by Mayo Clinic · Observational
The purpose of the study is to develop a clinical test based on breath analysis that can be used for disease diagnosis or prognosis.
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.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's enrollment of 46 is below the median of 167 across 681 observational studies indexed under Liver Diseases.
Browse Liver Diseases studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects who are undergoing evaluation and obtaining clinical care at Mayo Clinic in Florida will be enrolled
Exclusion Criteria:
No known medical conditions
Diagnostic Test: Collection of breath sample
Clinically diagnosed with cirrhosis
Diagnostic Test: Collection of breath sample
Persons with known test results for COVID-19 RNA
Diagnostic Test: Collection of breath sample
Persons with other medical diagnosis, no known liver disease, negative for COVID-19
Diagnostic Test: Collection of breath sample
Analysis of volatile organic compounds in breath
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.
Time frame: 1 day
Participants were enrolled from a specialized liver clinic. There was a need to ensure that sample collection and analysis could be performed within a controlled environment that did not pose risk of exposure or transmission of COVID-19 virus. As this could not be assured at the time, participants were not enrolled for the COVID-19 and other arms.
| Milestone | Healthy Patients | Cirrhosis Patients |
|---|---|---|
| Started | 11 | 35 |
| Completed | 11 | 35 |
| Not completed | 0 | 0 |
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.
| Participants | Healthy Patients | Cirrhosis Patients |
|---|---|---|
| Breath Volatile Organic Compound Profiles | 11 | 35 |
Collected over 1 day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Healthy Patients | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Cirrhosis Patients | 0/35 (0%) | 0/35 (0%) | 0/35 (0%) |
sequentially enrolled patients
| Age, Categorical(Participants) | Healthy Patients | Cirrhosis Patients | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 11 | 32 | 43 |
| >=65 years | 0 | 3 | 3 |
| Age, Continuous(years) | Healthy Patients | Cirrhosis Patients | Total |
|---|---|---|---|
| Median | 45 (24 to 60) | 61 (33 to 76) | 57 (24 to 76) |
| Sex: Female, Male(Participants) | Healthy Patients | Cirrhosis Patients | Total |
|---|---|---|---|
| Female | 6 | 17 | 23 |
| Male | 5 | 18 | 23 |
| Race and Ethnicity Not Collected(Participants) | Healthy Patients | Cirrhosis Patients | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Healthy Patients | Cirrhosis Patients | Total |
|---|---|---|---|
| United States | 11 | 35 | 46 |
| Number of subjects enrolled(participants) | Healthy Patients | Cirrhosis Patients | Total |
|---|---|---|---|
| Number | 11 | 35 | 46 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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