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

Completed

Conditions studied: Lung Cancer

In brief

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.

Key facts

Study ID

NCT01309087

Run by

Allegro Diagnostics, Corp.

People needed

756

Starts

2009-01-01

Expected to finish

2013-05-01

Last updated by the study team

2014-03-26

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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