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

Lung Cancer Clinical Trial

— AEGIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01309087
• Other study ID #: ADx-0001: AEGIS CLIA
• Status: Completed
• Phase: N/A
• First received: March 3, 2011
• Last updated: March 24, 2014
• Start date: January 2009
• Est. completion date: May 2013

Study information

• Verified date: March 2014
• Source: Allegro Diagnostics, Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review BoardCanada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 756
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
Canada	University of British Columbia	Vancouver	British Columbia
Ireland	Trinity College	Dublin
United States	Georgia Lung Associates	Austell	Georgia
United States	University of Alabama	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	University of Virginia	Charlottesville	Virginia
United States	University of Missouri	Columbia	Missouri
United States	Indiana University	Indianapolis	Indiana
United States	Vanderbilt University	Nashville	Tennessee
United States	LSU	New Orleans	Louisiana
United States	Columbia University	New York	New York
United States	New York University	New York	New York
United States	Temple University	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (15)

Lead Sponsor

Collaborator

Allegro Diagnostics, Corp.

Beth Israel Deaconess Medical Center, Columbia University, Georgia Lung Associates, Indiana University, Louisiana State University Health Sciences Center in New Orleans, New York University, Temple University, University of Alabama at Birmingham, University of British Columbia, University of Dublin, Trinity College, University of Missouri-Columbia, University of Pennsylvania, University of Virginia, Vanderbilt University

Countries where clinical trial is conducted

United States,  Canada,  Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Lung Cancer		One year from enrollment	No