NCT02123030

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
728

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 7, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 22, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 25, 2014

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2018

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

6.1 years

First QC Date

April 22, 2014

Last Update Submit

June 15, 2021

Conditions

Lung CancerPulmonary Disease

Keywords

Lung cancerpulmonary disease

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

Experimental

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

Control

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

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Those fitting inclusionary criteria between 20 and 85 years of age, with or without history of pulmonary disease or cancer.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

James Graham Brown Cancer Center-University of Louisville

Louisville, Kentucky, 40202, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Breathe samples

MeSH Terms

Conditions

Lung NeoplasmsLung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsRespiratory Tract Diseases

Study Officials

  • Xiao-An Fu, PhD

    James Graham Brown Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 22, 2014

First Posted

April 25, 2014

Study Start

November 7, 2012

Primary Completion

November 28, 2018

Study Completion

November 28, 2018

Last Updated

June 18, 2021

Record last verified: 2021-06

Locations

US(1)