Development of a Breath Analysis Test for Disease Diagnosis and Prognosis
Overview
- Phase
- N/A
- Intervention
- Collection of breath sample
- Conditions
- Liver Diseases
- Sponsor
- Mayo Clinic
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Breath Volatile Organic Compound Profiles
- Status
- Completed
- Last Updated
- 3 months ago
Overview
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.
Investigators
Tushar Patel
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •Able to provide informed consent
Exclusion Criteria
- Not provided
Arms & Interventions
Normal
No known medical conditions
Intervention: Collection of breath sample
Liver Cirrhosis
Clinically diagnosed with cirrhosis
Intervention: Collection of breath sample
COVID-19 tested
Persons with known test results for COVID-19 RNA
Intervention: Collection of breath sample
Other
Persons with other medical diagnosis, no known liver disease, negative for COVID-19
Intervention: Collection of breath sample
Outcomes
Primary Outcomes
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.