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

Completed

• Conditions: Lung Cancer

• Registration Number: NCT01309087
• Lead Sponsor: Allegro Diagnostics, Corp.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2011-03-03
• Study First Submitted QC: 2011-03-03
• Study First Posted: 2011-03-04
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-24
• Last Update Posted: 2014-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 756

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Lung Cancer	One year from enrollment

Trial Locations

Locations (14)

Trinity College; 🇮🇪 Dublin, Ireland

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

Georgia Lung Associates; 🇺🇸 Austell, Georgia, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

New York University; 🇺🇸 New York, New York, United States

Columbia University; 🇺🇸 New York, New York, United States

LSU; 🇺🇸 New Orleans, Louisiana, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

University of Missouri; 🇺🇸 Columbia, Missouri, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Temple University; 🇺🇸 Philadelphia, Pennsylvania, United States