Breath Analysis Based Disease Biomarkers

Completed

• Conditions: COVID19; Liver Diseases; Liver Cancer

• Registration Number: NCT04341012
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2019-09-10
• Study First Submitted: 2020-04-07
• Study First Submitted QC: 2020-04-07
• Study First Posted: 2020-04-10
• Primary Completion: 2021-09-03
• Study Completion: 2021-09-03
• Results First Submitted: 2024-03-12
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-11
• Last Update Submitted: 2024-11-11
• Results First Posted: 2024-11-15
• Last Update Posted: 2024-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Able to provide informed consent

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States