Airway Epithelium Gene Expression: AEGIS IDE

NCT00746759 | Completed

• 1 other identifier: ADx-0001: IDE G090194
• Study Type: observational
• Target: 1,331
• Locations: 1 country
• Sites: 21

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.

Conditions

Lung Cancer

Keywords

Lung Cancer; Smoker; Former Smoker; Gene Expression; Bronchoscopy

Outcome Measures

Primary Outcomes (1)

• Lung Cancer Diagnosis (positive or negative)

  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

Study Arms (1)

Standard of Care

Device: Biomarker (not used as an intervention)

Interventions

Biomarker (not used as an intervention) DEVICE

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

Also known as: BronchoGen

Standard of Care

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (21)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

Pulmonary Associates of Arizona

Phoenix, Arizona, 85006, United States

Location

University of California- Davis

Sacramento, California, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

Yale Univeristy

New Haven, Connecticut, United States

Location

North Florida/South Georgia VA

Gainesville, Florida, 32608, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

LSU

New Orleans, Louisiana, 70112, United States

Location

St. Elizabeth's Medical Center

Boston, Massachusetts, 02135, United States

Location

University of Missouri

Columbia, Missouri, 65203, United States

Location

Pulmonary and Allergy Associates of New Jersey

Summit, New Jersey, 07901, United States

Location

Jamaica Hospital Medical Center

Jamaica, New York, 11418, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Cleveland Clinic

Cleveland, Ohio, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Dorn VA

Columbia, South Carolina, 29209, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Overlake Hospital

Bellevue, Washington, 98004, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Related Publications (2)

• Vachani A, Whitney DH, Parsons EC, Lenburg M, Ferguson JS, Silvestri GA, Spira A. Clinical Utility of a Bronchial Genomic Classifier in Patients With Suspected Lung Cancer. Chest. 2016 Jul;150(1):210-8. doi: 10.1016/j.chest.2016.02.636. Epub 2016 Feb 16.

  PMID: 26896702 DERIVED

• Silvestri GA, Vachani A, Whitney D, Elashoff M, Porta Smith K, Ferguson JS, Parsons E, Mitra N, Brody J, Lenburg ME, Spira A; AEGIS Study Team. A Bronchial Genomic Classifier for the Diagnostic Evaluation of Lung Cancer. N Engl J Med. 2015 Jul 16;373(3):243-51. doi: 10.1056/NEJMoa1504601. Epub 2015 May 17.

  PMID: 25981554 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Cells, Blood

MeSH Terms

Conditions

Lung Neoplasms; Smoking Cessation

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Health Behavior; Behavior

Study Officials

• Duncan Whitney, PhD

  Allegro Diagnostics

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2008
• First Posted: September 4, 2008
• Study Start: February 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: February 1, 2015
• Last Updated: June 4, 2015

Record last verified: 2015-06

Locations

US (21)