Breath Analysis Based Disease Biomarkers

NCT ID: NCT04341012

Last Updated: 2024-11-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-10

Study Completion Date

2021-09-03

Brief Summary

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

Detailed Description

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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.

Conditions

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Liver Diseases Liver Cancer COVID19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal

No known medical conditions

Collection of breath sample

Intervention Type DIAGNOSTIC_TEST

Analysis of volatile organic compounds in breath

Liver Cirrhosis

Clinically diagnosed with cirrhosis

Collection of breath sample

Intervention Type DIAGNOSTIC_TEST

Analysis of volatile organic compounds in breath

COVID-19 tested

Persons with known test results for COVID-19 RNA

Collection of breath sample

Intervention Type DIAGNOSTIC_TEST

Analysis of volatile organic compounds in breath

Other

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

Collection of breath sample

Intervention Type DIAGNOSTIC_TEST

Analysis of volatile organic compounds in breath

Interventions

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Collection of breath sample

Analysis of volatile organic compounds in breath

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Able to provide informed consent

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Tushar Patel

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tushar Patel

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Florida

Jacksonville, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 34847181 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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19-001971

Identifier Type: -

Identifier Source: org_study_id

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