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


N/A
21 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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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 AlabamaBirmingham, Alabama  
Medical University of South CarolinaCharleston, South Carolina  29425-0721
University of MissouriColumbia, Missouri  65212
St. Elizabeth's Medical CenterBoston, Massachusetts  02135-2997
Temple UniversityPhiladelphia, Pennsylvania  19140
Columbia UniversityNew York, New York  10032-3784
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Cleveland ClinicCleveland, Ohio  44195
Virginia Commonwealth UniversityRichmond, Virginia  
Indiana UniversityIndianapolis, Indiana  46202
University of WisconsinMadison,, Wisconsin  53792-5666
Pulmonary Associates of ArizonaPhoenix, Arizona  85006
University of California- DavisSacramento, California  
National Jewish HealthDenver, Colorado  80206
Yale UniveristyNew Haven, Connecticut  
North Florida/South Georgia VAGainesville, Florida  32608
LSUNew Orleans, Louisiana  70112
Pulmonary and Allergy Associates of New JerseySummit, New Jersey  07901
Jamaica Hospital Medical CenterJamaica, New York  11418
Dorn VAColumbia, South Carolina  29209
Overlake HospitalBellevue, Washington  98004