Airway Epithelium Gene Expression: AEGIS IDE

Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer: AEGIS IDE

Sponsors

Lead Sponsor: Allegro Diagnostics, Corp.

Collaborator: University of Pennsylvania
Columbia University
Temple University
Indiana University
University of Alabama at Birmingham
University of Missouri-Columbia
Louisiana State University Health Sciences Center in New Orleans
University of Wisconsin, Madison
Medical University of South Carolina
National Jewish Health
Overlake Hospital Bellevue WA
Pulmonary and Allergy Associates of New Jersey
Pulmonary Associates of Arizona
William Jennings Bryan Dorn VA Medical Center
Virginia Commonwealth University
Jamaica Hospital Medical Center
North Florida/South Georgia Veterans Health System
Steward St. Elizabeth's Medical Center of Boston, Inc.
University of California, Davis
Yale University
The Cleveland Clinic

Source Allegro Diagnostics, Corp.
Brief Summary

The purpose of the research study is to develop a new, more sensitive, and less invasive test for diagnosing lung cancer at an earlier stage, when it can more easily be cured. The investigators hypothesize that certain genes are expressed differently in current and former smokers who have lung cancer, and this difference in gene expression may be a biomarker for lung cancer.

Detailed Description

Allegro Diagnostics is funding this multi-center study to validate and extend a new diagnostic tool measuring global gene expression in airway epithelial cells obtained at routine bronchoscopy in suspect lung cancer patients. The test, which is highly sensitive and specific for lung cancer, measures the levels of expression of genes in cells brushed from the large bronchi during diagnostic bronchoscopy. Similar brushings of epithelial cells from the nose will be analyzed to determine if gene expression in these cells can be used as a screening tool in subjects who may have now or be at risk for developing lung cancer in the future.

Overall Status Completed
Start Date 2010-02-01
Completion Date 2015-02-01
Primary Completion Date 2014-12-01
Study Type Observational
Primary Outcome
Measure Time Frame
Lung Cancer Diagnosis (positive or negative) 12 months
Enrollment 1331
Condition
Intervention

Intervention Type: Device

Intervention Name: Biomarker (not used as an intervention)

Description: This study is an observational study. There is no intervention.

Arm Group Label: Standard of Care

Other Name: BronchoGen

Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

Inclusion Criteria: - Patients being evaluated for the diagnosis of possible lung cancer or "rule out lung cancer" and undergoing clinically indicated bronchoscopy - All patients are required to be at least 21 years of age and be able to understand and sign the informed consent form - Patient must be a current or former cigarette smoker Exclusion Criteria: - A pulmonary physician does not recommend that bronchoscopy be performed - Inability to understand the written consent form and comply with requirements of the study - History of prior primary lung cancer - Immediately prior to bronchoscopy, the patient has been on a mechanical ventilator for >24 consecutive hours.

Gender:

All

Minimum Age:

21 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Duncan Whitney, PhD Study Director Allegro Diagnostics
Location
Facility:
University of Alabama | Birmingham, Alabama, 35294, United States
Pulmonary Associates of Arizona | Phoenix, Arizona, 85006, United States
University of California- Davis | Sacramento, California, United States
National Jewish Health | Denver, Colorado, 80206, United States
Yale Univeristy | New Haven, Connecticut, United States
North Florida/South Georgia VA | Gainesville, Florida, 32608, United States
Indiana University | Indianapolis, Indiana, 46202, United States
LSU | New Orleans, Louisiana, 70112, United States
St. Elizabeth's Medical Center | Boston, Massachusetts, 02135, United States
University of Missouri | Columbia, Missouri, 65203, United States
Pulmonary and Allergy Associates of New Jersey | Summit, New Jersey, 07901, United States
Jamaica Hospital Medical Center | Jamaica, New York, 11418, United States
Columbia University | New York, New York, 10032, United States
Cleveland Clinic | Cleveland, Ohio, United States
University of Pennsylvania | Philadelphia, Pennsylvania, 19104, United States
Temple University | Philadelphia, Pennsylvania, 19140, United States
Medical University of South Carolina | Charleston, South Carolina, 29425, United States
Dorn VA | Columbia, South Carolina, 29209, United States
Virginia Commonwealth University | Richmond, Virginia, 23298, United States
Overlake Hospital | Bellevue, Washington, 98004, United States
University of Wisconsin | Madison, Wisconsin, 53792, United States
Location Countries

United States

Verification Date

2015-06-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Standard of Care

Acronym AEGIS IDE
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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