Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer: AEGIS CLIA
NCT ID: NCT01309087
Last Updated: 2014-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
756 participants
OBSERVATIONAL
2009-01-31
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
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
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.
21 Years
ALL
No
Sponsors
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Beth Israel Deaconess Medical Center
OTHER
Columbia University
OTHER
Vanderbilt University
OTHER
University of British Columbia
OTHER
University of Pennsylvania
OTHER
New York University
OTHER
Temple University
OTHER
Indiana University
OTHER
University of Alabama at Birmingham
OTHER
University of Virginia
OTHER
University of Missouri-Columbia
OTHER
Louisiana State University Health Sciences Center in New Orleans
OTHER
University of Dublin, Trinity College
OTHER
Georgia Lung Associates PC
OTHER
Allegro Diagnostics, Corp.
INDUSTRY
Responsible Party
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Principal Investigators
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Duncan Whitney, PhD
Role: STUDY_DIRECTOR
Allegro Diagnostics
Locations
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University of Alabama
Birmingham, Alabama, United States
Georgia Lung Associates
Austell, Georgia, United States
Indiana University
Indianapolis, Indiana, United States
LSU
New Orleans, Louisiana, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Missouri
Columbia, Missouri, United States
New York University
New York, New York, United States
Columbia University
New York, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
Vanderbilt University
Nashville, Tennessee, United States
University of Virginia
Charlottesville, Virginia, United States
University of British Columbia
Vancouver, British Columbia, Canada
Trinity College
Dublin, , Ireland
Countries
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References
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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.
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.
Other Identifiers
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ADx-0001: AEGIS CLIA
Identifier Type: -
Identifier Source: org_study_id
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