Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer: AEGIS II
21 Years
N/A
Both
Lung Cancer
Trial Information
Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer: AEGIS II
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.
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.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Lung Cancer Diagnosis (positive or negative)
Outcome Description:
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.
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
Duncan Whitney, PhD
Investigator Role:
Study Director
Investigator Affiliation:
Allegro Diagnostics
Authority:
United States: Institutional Review Board
Study ID:
ADx-0001: IDE G090194
NCT ID:
NCT00746759
Start Date:
February 2010
Completion Date:
December 2013
Related Keywords:
- Lung Cancer
- Lung Cancer
- Smoker
- Former Smoker
- Gene Expression
- Bronchoscopy
- Lung Neoplasms
Name | Location |
|---|---|
| University of Alabama | Birmingham, Alabama |
| Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
| University of Missouri | Columbia, Missouri 65212 |
| St. Elizabeth's Medical Center | Boston, Massachusetts 02135-2997 |
| Temple University | Philadelphia, Pennsylvania 19140 |
| Columbia University | New York, New York 10032-3784 |
| University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
| Cleveland Clinic | Cleveland, Ohio 44195 |
| Virginia Commonwealth University | Richmond, Virginia |
| Indiana University | Indianapolis, Indiana 46202 |
| University of Wisconsin | Madison,, Wisconsin 53792-5666 |
| Pulmonary Associates of Arizona | Phoenix, Arizona 85006 |
| University of California- Davis | Sacramento, California |
| National Jewish Health | Denver, Colorado 80206 |
| Yale Univeristy | New Haven, Connecticut |
| North Florida/South Georgia VA | Gainesville, Florida 32608 |
| LSU | New Orleans, Louisiana 70112 |
| Pulmonary and Allergy Associates of New Jersey | Summit, New Jersey 07901 |
| Jamaica Hospital Medical Center | Jamaica, New York 11418 |
| Dorn VA | Columbia, South Carolina 29209 |
| Overlake Hospital | Bellevue, Washington 98004 |
