A Micro/Nano Device for Exhaled Breath Analysis | NCT02123030

Studies
A Micro/Nano Device for Exhaled Breath Analysis

NCT02123030

Sponsor

University of Louisville

Status

Completed

Last Update Posted

Jun 18, 2021Actual

Enrollment

728Actual

Phase

Not provided

Conditions

Lung Cancer
Pulmonary Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 7, 2012Actual

Primary Completion Date

Nov 28, 2018Actual

Completion Date

Nov 28, 2018Actual

First Submitted Date

Apr 22, 2014

First Submission Date that Met QC Criteria

Apr 24, 2014

First Posted Date

Apr 25, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2021

Last Update Posted Date

Jun 18, 2021Actual

Name	Class
James Graham Brown Cancer Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

728Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xiao-An Fu, PhD	James Graham Brown Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
James Graham Brown Cancer Center-University of Louisville		Louisville	Kentucky	40202	United States

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms
D008171	Lung Diseases

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

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Browse Branches

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