Breath Analysis Based Disease Biomarkers

NCT04341012 | Completed Results

• 1 other identifier: 19-001971
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer; Liver Diseases; COVID19

Outcome Measures

Primary Outcomes (1)

• Breath Volatile Organic Compound Profiles

  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.

  1 day

Study Arms (4)

Normal

No known medical conditions

Diagnostic Test: Collection of breath sample

Liver Cirrhosis

Clinically diagnosed with cirrhosis

Diagnostic Test: Collection of breath sample

COVID-19 tested

Persons with known test results for COVID-19 RNA

Diagnostic Test: Collection of breath sample

Other

Persons with other medical diagnosis, no known liver disease, negative for COVID-19

Diagnostic Test: Collection of breath sample

Interventions

Collection of breath sample DIAGNOSTIC_TEST

Analysis of volatile organic compounds in breath

COVID-19 tested; Liver Cirrhosis; Normal; Other

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Able to provide informed consent

You may not qualify if:

• None

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Related Publications (1)

• Thomas JN, Roopkumar J, Patel T. Machine learning analysis of volatolomic profiles in breath can identify non-invasive biomarkers of liver disease: A pilot study. PLoS One. 2021 Nov 30;16(11):e0260098. doi: 10.1371/journal.pone.0260098. eCollection 2021.

  PMID: 34847181 RESULT

MeSH Terms

Conditions

Liver Diseases; Liver Neoplasms; COVID-19

Condition Hierarchy (Ancestors)

Digestive System Diseases; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Tushar Patel
• Organization: Mayo Clinic

patel.tushar@mayo.edu

9049532000

Study Officials

• Tushar Patel

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 10, 2020
• Study Start: September 10, 2019
• Primary Completion: September 3, 2021
• Study Completion: September 3, 2021
• Last Updated: January 26, 2026
• Results First Posted: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)