Clinical trial NCT01309087: Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer: AEGIS CLIA
Official title: Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer: AEGIS CLIA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: Gene Expression
Lung Cancer
Smoking
Lead sponsor: Allegro Diagnostics, Corp.
Sponsor class: INDUSTRY
Collaborators: name: Beth Israel Deaconess Medical Center
name: Columbia University
name: Vanderbilt University
name: University of British Columbia
name: University of Pennsylvania
name: New York University
name: Temple University
name: Indiana University
name: University of Alabama at Birmingham
name: University of Virginia
name: University of Missouri-Columbia
name: Louisiana State University Health Sciences Center in New Orleans
name: University of Dublin, Trinity College
name: Georgia Lung Associates PC
First posted: 2011-03-04
Enrollment: 756
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 who are undergoing clinically indicated bronchoscopy for rule out lung cancre and have a history of cigarette smoking

Brief summary: The primary objective of this study is to substantiate prediction accuracy(with a tighter 95% confidence interval compared to current diagnostic modalities), of a lung cancer biomarker for risk stratification of patients into high and low risk categories to aid in clinical evaluation of the patient.


Eligibility criteria: Inclusion Criteria:

1. The patient is being evaluated for the diagnosis of possible lung cancer or "rule out lung cancer" and is indicated for bronchoscopy.
2. The patient is undergoing bronchoscopy
3. ≥ 21 years of age
4. Patient meets local site's standard of care (SOC) for performing diagnostic bronchoscopy
5. The patient is a current or former cigarette smoker (defined as having smoked \>100 cigarettes in their lifetime.

Exclusion Criteria:

1. The Pulmonary physician does not recommend that bronchoscopy be performed
2. The patient is unable to be consented into the study or unable to comply with requirements of the study
3. The patient has previously been diagnosed with primary lung cancer
4. Immediately prior to bronchoscopy, the patient has been on a mechanical ventilator for ≥ 24 consecutive hours.

Primary outcomes:
measure: Primary Lung Cancer
timeFrame: One year from enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Austell
country: United States
facility: Georgia Lung Associates
state: Georgia
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: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: New York
country: United States
facility: New York University
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Dublin
country: Ireland
facility: Trinity College
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.