A Micro/Nano Device for Exhaled Breath Analysis

NCT ID: NCT02123030

Last Updated: 2021-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

728 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-07

Study Completion Date

2018-11-28

Brief Summary

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Use of a microfabricated silicon device to concentrate ultra trace volatile organic compounds (VOCs) in human exhaled breath for quantitative analysis of VOCs.

Detailed Description

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Will use Fourier Transform Mass Spectrometry (FT-MS) and Gas Chromatography-Mass Spectrometry (GC-MS) to analyze concentrated VOCs. The purpose of this study is to search for disease-related markers in the breath in subjects with known or suspected lung or other cancer, or pulmonary disease.

Conditions

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Lung Cancer Pulmonary Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Experimental

patients with pulmonary disease; and, patients with known or suspected lung or other cancers

No interventions assigned to this group

Control

healthy subjects (for example, family members of the patient or graduate students

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* For controlled (healthy) subjects - we are seeking persons who do not have a known history of cancer or pulmonary disease.
* Both smokers and nonsmokers are invited to participate as control subjects.
* For experimental subjects, we are seeking persons with pulmonary disease but no known history of cancer, as identified by the investigators during routine clinic or office visits.
* Additionally for experimental subjects, we are seeking persons with known or suspected lung or other cancers, as identified by the investigators during routine clinic or office visits.
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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James Graham Brown Cancer Center

OTHER

Sponsor Role collaborator

University of Louisville

OTHER

Sponsor Role lead

Responsible Party

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Xiao-An Fu

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiao-An Fu, PhD

Role: PRINCIPAL_INVESTIGATOR

James Graham Brown Cancer Center

Locations

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James Graham Brown Cancer Center-University of Louisville

Louisville, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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10.0642

Identifier Type: -

Identifier Source: org_study_id

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