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Completed

NCT Number: NCT02123030

A Micro/Nano Device for Exhaled Breath Analysis

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

Completed

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pulmonary Disease Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

James Graham Brown Cancer Center-University of Louisville

Louisville, Kentucky, 40202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Detection of disease related markers (biomarkers) from concentrated volatile organic compounds in breath samples

    Time frame: 1 day (After sample collection)

    The concentrated volatile organic compounds in exhaled breath samples will be analyzed by statistical software for search for disease related markers (biomarkers).

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Collaborators

  • James Graham Brown Cancer Center

Registry information

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Apr 25, 2014
Registry last updated
Jun 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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