Breath Analysis Based Disease Biomarkers of COVID-19 and Other Diseases

March 29, 2022 updated by: Tushar Patel, Mayo Clinic

Development of a Breath Analysis Test for Disease Diagnosis and Prognosis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who are undergoing evaluation and obtaining clinical care at Mayo Clinic in Florida will be enrolled

Description

Inclusion Criteria:

  • Able to provide informed consent

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal
No known medical conditions
Diagnostic test: Collection of breath sample
Analysis of volatile organic compounds in breath
Liver Cirrhosis
Clinically diagnosed with cirrhosis
Diagnostic test: Collection of breath sample
Analysis of volatile organic compounds in breath
COVID-19 tested
Persons with known test results for COVID-19 RNA
Diagnostic test: Collection of breath sample
Analysis of volatile organic compounds in breath
Other
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breath volatile organic compound profiles
Time Frame: 1 day
Analysis of profiles of volatile organic compounds present in exhaled breath
1 day
Utility of breath profiles for disease diagnosis or prognosis
Time Frame: 14 days
Diagnosis or prognostic utility of breath volatile organic compound profiles
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Tushar Patel, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 10, 2019

Primary Completion (ACTUAL)

September 3, 2021

Study Completion (ACTUAL)

September 3, 2021

Study Registration Dates

First Submitted

April 7, 2020

First Submitted That Met QC Criteria

April 7, 2020

First Posted (ACTUAL)

April 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 29, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-001971

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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