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NCT02123030 Clinical Trial

A Micro/Nano Device for Exhaled Breath Analysis

Lung Cancer Clinical Trial

Official title:
A Micro/Nano Device for Exhaled Breath Analysis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02123030
Other study ID # 10.0642
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 7, 2012
Est. completion date November 28, 2018

Study information
Verified date June 2021
Source University of Louisville
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 728
Est. completion date November 28, 2018
Est. primary completion date November 28, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 85 Years
Eligibility 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. Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States James Graham Brown Cancer Center-University of Louisville Louisville Kentucky

Sponsors (2)
Lead Sponsor Collaborator
University of Louisville James Graham Brown Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Detection of disease related markers (biomarkers) from concentrated volatile organic compounds in breath samples The concentrated volatile organic compounds in exhaled breath samples will be analyzed by statistical software for search for disease related markers (biomarkers). 1 day (After sample collection)
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