Airway Epithelium Gene Expression: AEGIS IDE (AEGIS IDE)

June 2, 2015 updated by: Allegro Diagnostics, Corp.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1331

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients of enrolled medical centers who are undergoing clinically indicated bronchoscopy for suspect lung cancer and who are current or former cigarette smokers.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Standard of Care
Device: Biomarker (not used as an intervention)
This study is an observational study. There is no intervention.
Other Names:
  • BronchoGen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung Cancer Diagnosis (positive or negative)
Time Frame: 12 months
Patients may be followed at 12 months post bronchoscopy to finalize diagnosis if diagnosis had not previously been confirmed. The biomarker score will be compared to the standard diagnosis to evaluate the sensitivity, specificity, and negative predictive values of the biomarker.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allegro Diagnostics, Corp.

Collaborators

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

Investigators

  • Study Director: Duncan Whitney, PhD, Allegro Diagnostics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

September 3, 2008

First Submitted That Met QC Criteria

September 3, 2008

First Posted (Estimate)

September 4, 2008

Study Record Updates

Last Update Posted (Estimate)

June 4, 2015

Last Update Submitted That Met QC Criteria

June 2, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADx-0001: IDE G090194

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 register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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