Breath Analysis Based Disease Biomarkers

The purpose of the study is to develop a clinical test based on breath analysis that can be used for disease diagnosis or prognosis.

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Key information

Conditions

Liver Diseases COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Digestive System Diseases Digestive System Neoplasms Infections Liver Cancer Liver Neoplasms Lung Diseases Neoplasms Neoplasms by Site Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Able to provide informed consent

Exclusion criteria

None

Treatment and study plan

Collection of breath sample

Diagnostic Test

Analysis of volatile organic compounds in breath

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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Development of a Breath Analysis Test for Disease Diagnosis and Prognosis

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Apr 10, 2020
Registry last updated: Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed