Airway Epithelium Gene Expression: AEGIS IDE

Lung Cancer Clinical Trial

— AEGIS IDE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00746759
• Other study ID #: ADx-0001: IDE G090194
• Status: Completed
• Phase: N/A
• First received: September 3, 2008
• Last updated: June 2, 2015
• Start date: February 2010
• Est. completion date: February 2015

Study information

• Verified date: June 2015
• Source: Allegro Diagnostics, Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The purpose of the research study is to develop a new, more sensitive, and less invasive test for diagnosing lung cancer at an earlier stage, when it can more easily be cured. The investigators hypothesize that certain genes are expressed differently in current and former smokers who have lung cancer, and this difference in gene expression may be a biomarker for lung cancer.

Description:

Allegro Diagnostics is funding this multi-center study to validate and extend a new diagnostic tool measuring global gene expression in airway epithelial cells obtained at routine bronchoscopy in suspect lung cancer patients. The test, which is highly sensitive and specific for lung cancer, measures the levels of expression of genes in cells brushed from the large bronchi during diagnostic bronchoscopy. Similar brushings of epithelial cells from the nose will be analyzed to determine if gene expression in these cells can be used as a screening tool in subjects who may have now or be at risk for developing lung cancer in the future.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1331
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Patients being evaluated for the diagnosis of possible lung cancer or "rule out lung cancer" and undergoing clinically indicated bronchoscopy

• All patients are required to be at least 21 years of age and be able to understand and sign the informed consent form

• Patient must be a current or former cigarette smoker

Exclusion Criteria:

• A pulmonary physician does not recommend that bronchoscopy be performed

• Inability to understand the written consent form and comply with requirements of the study

• History of prior primary lung cancer

• 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

Intervention

Device:
• Biomarker (not used as an intervention)
This study is an observational study. There is no intervention.

Locations

Country	Name	City	State
United States	Overlake Hospital	Bellevue	Washington
United States	University of Alabama	Birmingham	Alabama
United States	St. Elizabeth's Medical Center	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Cleveland Clinic	Cleveland	Ohio
United States	Dorn VA	Columbia	South Carolina
United States	University of Missouri	Columbia	Missouri
United States	National Jewish Health	Denver	Colorado
United States	North Florida/South Georgia VA	Gainesville	Florida
United States	Indiana University	Indianapolis	Indiana
United States	Jamaica Hospital Medical Center	Jamaica	New York
United States	University of Wisconsin	Madison	Wisconsin
United States	Yale Univeristy	New Haven	Connecticut
United States	LSU	New Orleans	Louisiana
United States	Columbia University	New York	New York
United States	Temple University	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Pulmonary Associates of Arizona	Phoenix	Arizona
United States	Virginia Commonwealth University	Richmond	Virginia
United States	University of California- Davis	Sacramento	California
United States	Pulmonary and Allergy Associates of New Jersey	Summit	New Jersey

Sponsors (22)

Lead Sponsor

Collaborator

Allegro Diagnostics, Corp.

Columbia University, Indiana University, Jamaica Hospital Medical Center, Louisiana State University Health Sciences Center in New Orleans, Medical University of South Carolina, National Jewish Health, North Florida/South Georgia Veterans Health System, Overlake Hospital Bellevue WA, Pulmonary and Allergy Associates of New Jersey, Pulmonary Associates of Arizona, Steward St. Elizabeth's Medical Center of Boston, Inc., Temple University, The Cleveland Clinic, University of Alabama at Birmingham, University of California, Davis, University of Missouri-Columbia, University of Pennsylvania, University of Wisconsin, Madison, Virginia Commonwealth University, William Jennings Bryan Dorn VA Medical Center, Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung Cancer Diagnosis (positive or negative)	Patients may be followed at 12 months post bronchoscopy to finalize diagnosis if diagnosis had not previously been confirmed. The biomarker score will be compared to the standard diagnosis to evaluate the sensitivity, specificity, and negative predictive values of the biomarker.	12 months	No

External Links

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