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

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT04341012
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Actual Duration (Months): 23.8
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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	Phase
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.

Study Design

• 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: Sep 10, 2019
• Actual Primary Completion Date: Sep 3, 2021
• Actual Study Completion Date: Sep 3, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Breath volatile organic compound profiles [1 day]

   Analysis of profiles of volatile organic compounds present in exhaled breath

2. Utility of breath profiles for disease diagnosis or prognosis [14 days]

   Diagnosis or prognostic utility of breath volatile organic compound profiles

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Able to provide informed consent

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Florida	Jacksonville	Florida	United States	32224

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Tushar Patel, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Tushar Patel, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT04341012
• Other Study ID Numbers: 19-001971
• First Posted: Apr 10, 2020
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Liver Diseases

Study Results

No Results Posted as of Mar 31, 2022