Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer: AEGIS CLIA (AEGIS)

• ClinicalTrials.gov Identifier: NCT01309087
• Recruitment Status: Completed
• First Posted: March 4, 2011
• Last Update Posted: March 26, 2014
• Sponsor: Allegro Diagnostics, Corp.
• Collaborators: Beth Israel Deaconess Medical Center; Columbia University; Vanderbilt University; University of British Columbia; University of Pennsylvania; New York University; Temple University; Indiana University; University of Alabama at Birmingham; University of Virginia; University of Missouri-Columbia; Louisiana State University Health Sciences Center in New Orleans; University of Dublin, Trinity College; Georgia Lung Associates PC
• Information provided by (Responsible Party): Allegro Diagnostics, Corp.

Study Description

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.

Condition or disease
Lung Cancer

Study Design

• Study Type: Observational
• Actual Enrollment: 756 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer: AEGIS CLIA
• Study Start Date: January 2009
• Actual Primary Completion Date: May 2013
• Actual Study Completion Date: May 2013

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Primary Lung Cancer [ Time Frame: One year from enrollment ]

Biospecimen Retention:   Samples With DNA

Cells, Blood

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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

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.

Contacts and Locations

Locations

United States, Alabama

University of Alabama

Birmingham, Alabama, United States, 35294

United States, Georgia

Georgia Lung Associates

Austell, Georgia, United States, 30106

United States, Indiana

Indiana University

Indianapolis, Indiana, United States, 46202

United States, Louisiana

LSU

New Orleans, Louisiana, United States, 70112

United States, Massachusetts

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

United States, Missouri

University of Missouri

Columbia, Missouri, United States, 65203

United States, New York

New York University

New York, New York, United States, 10016

Columbia University

New York, New York, United States, 10032

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Temple University

Philadelphia, Pennsylvania, United States, 19140

United States, Tennessee

Vanderbilt University

Nashville, Tennessee, United States, 37232

United States, Virginia

University of Virginia

Charlottesville, Virginia, United States, 22908

Canada, British Columbia

University of British Columbia

Vancouver, British Columbia, Canada

Ireland

Trinity College

Dublin, Ireland, 8

Sponsors and Collaborators

Allegro Diagnostics, Corp.

Beth Israel Deaconess Medical Center

Columbia University

Vanderbilt University

University of British Columbia

University of Pennsylvania

New York University

Temple University

Indiana University

University of Alabama at Birmingham

University of Virginia

University of Missouri-Columbia

Louisiana State University Health Sciences Center in New Orleans

University of Dublin, Trinity College

Georgia Lung Associates PC

Investigators

• Study Director: Duncan Whitney, PhD; Allegro Diagnostics

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Allegro Diagnostics, Corp.
• ClinicalTrials.gov Identifier: NCT01309087 History of Changes
• Other Study ID Numbers: ADx-0001: AEGIS CLIA
• First Posted: March 4, 2011
• Last Update Posted: March 26, 2014
• Last Verified: March 2014

Keywords provided by Allegro Diagnostics, Corp.:

Gene Expression; Lung Cancer; Smoking

Additional relevant MeSH terms:

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