COVID19, Liver Cancer, Liver Diseases
Conditions
Brief 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.
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.
Interventions
DIAGNOSTIC_TESTCollection of breath sample
Analysis of volatile organic compounds in breath
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Able to provide informed consent
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breath Volatile Organic Compound Profiles | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTushar Patel
Mayo Clinic
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Healthy Patients Patients with no known liver disease or cirrhosis | 11 |
| Cirrhosis Patients Patients with cirrhosis of the liver | 35 |
| Total | 46 |
Baseline characteristics
| Characteristic | Cirrhosis Patients | Total | Healthy Patients |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 3 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants | 43 Participants | 11 Participants |
| Age, Continuous | 61 years | 57 years | 45 years |
| Number of subjects enrolled | 35 participants | 46 participants | 11 participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 35 participants | 46 participants | 11 participants |
| Sex: Female, Male Female | 17 Participants | 23 Participants | 6 Participants |
| Sex: Female, Male Male | 18 Participants | 23 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 35 |
| other Total, other adverse events | 0 / 11 | 0 / 35 |
| serious Total, serious adverse events | 0 / 11 | 0 / 35 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthy Patients | Breath Volatile Organic Compound Profiles | 11 Participants |
| Cirrhosis Patients | Breath Volatile Organic Compound Profiles | 35 Participants |