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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04341012
Recruitment Status : Completed
First Posted : April 10, 2020
Last Update Posted : March 31, 2022
Sponsor:
Information provided by (Responsible Party):
Tushar Patel, 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.

Condition or disease Intervention/treatment
Liver Diseases Liver Cancer COVID19 Diagnostic Test: Collection of breath sample

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.

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of a Breath Analysis Test for Disease Diagnosis and Prognosis
Actual Study Start Date : September 10, 2019
Actual Primary Completion Date : September 3, 2021
Actual Study Completion Date : September 3, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Breath volatile organic compound profiles [ Time Frame: 1 day ]
    Analysis of profiles of volatile organic compounds present in exhaled breath

  2. Utility of breath profiles for disease diagnosis or prognosis [ Time Frame: 14 days ]
    Diagnosis or prognostic utility of breath volatile organic compound profiles



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects who are undergoing evaluation and obtaining clinical care at Mayo Clinic in Florida will be enrolled
Criteria

Inclusion Criteria:

  • Able to provide informed consent

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04341012


Locations
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United States, Florida
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Tushar Patel Mayo Clinic
Additional Information:
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Responsible Party: Tushar Patel, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04341012    
Other Study ID Numbers: 19-001971
First Posted: April 10, 2020    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Liver Diseases
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Digestive System Diseases