Clinical trial NCT00746759: Airway Epithelium Gene Expression: AEGIS IDE
Official title: Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer: AEGIS IDE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: Lung Cancer
Smoker
Former Smoker
Gene Expression
Bronchoscopy
Lead sponsor: Allegro Diagnostics, Corp.
Sponsor class: INDUSTRY
Collaborators: name: University of Pennsylvania
name: Columbia University
name: Temple University
name: Indiana University
name: University of Alabama at Birmingham
name: University of Missouri-Columbia
name: Louisiana State University Health Sciences Center in New Orleans
name: University of Wisconsin, Madison
name: Medical University of South Carolina
name: National Jewish Health
name: Overlake Hospital Bellevue WA
name: Pulmonary and Allergy Associates of New Jersey
name: Pulmonary Associates of Arizona
name: William Jennings Bryan Dorn VA Medical Center
name: Virginia Commonwealth University
name: Jamaica Hospital Medical Center
name: North Florida/South Georgia Veterans Health System
name: Steward St. Elizabeth's Medical Center of Boston, Inc.
name: University of California, Davis
name: Yale University
name: The Cleveland Clinic
First posted: 2008-09-04
Enrollment: 1331
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Lung Cancer Diagnosis (positive or negative)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Phoenix
country: United States
facility: Pulmonary Associates of Arizona
state: Arizona
city: Sacramento
country: United States
facility: University of California- Davis
state: California
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: New Haven
country: United States
facility: Yale Univeristy
state: Connecticut
city: Gainesville
country: United States
facility: North Florida/South Georgia VA
state: Florida
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: New Orleans
country: United States
facility: LSU
state: Louisiana
city: Boston
country: United States
facility: St. Elizabeth's Medical Center
state: Massachusetts
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Summit
country: United States
facility: Pulmonary and Allergy Associates of New Jersey
state: New Jersey
city: Jamaica
country: United States
facility: Jamaica Hospital Medical Center
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Columbia
country: United States
facility: Dorn VA
state: South Carolina
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Bellevue
country: United States
facility: Overlake Hospital
state: Washington
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: Allegro Diagnostics
name: Duncan Whitney, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.