Airway Epithelium Gene Expression: AEGIS IDE

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Pennsylvania
Columbia University
Temple University
Indiana University
University of Alabama at Birmingham
University of Missouri-Columbia
Louisiana State University Health Sciences Center in New Orleans
University of Wisconsin, Madison
Medical University of South Carolina
National Jewish Health
Overlake Hospital Bellevue WA
Pulmonary and Allergy Associates of New Jersey
Pulmonary Associates of Arizona
William Jennings Bryan Dorn VA Medical Center
Virginia Commonwealth University
Jamaica Hospital Medical Center
North Florida/South Georgia Veterans Health System
Steward St. Elizabeth's Medical Center of Boston, Inc.
University of California, Davis
Yale University
The Cleveland Clinic
Information provided by (Responsible Party):
Allegro Diagnostics, Corp.
ClinicalTrials.gov Identifier:
NCT00746759
First received: September 3, 2008
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Lung Cancer
Device: Biomarker (not used as an intervention)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer: AEGIS IDE

Resource links provided by NLM:


Further study details as provided by Allegro Diagnostics, Corp.:

Primary Outcome Measures:
  • Lung Cancer Diagnosis (positive or negative) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Cells, Blood


Enrollment: 1331
Study Start Date: February 2010
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Standard of Care Device: Biomarker (not used as an intervention)
This study is an observational study. There is no intervention.
Other Name: BronchoGen

Detailed 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients of enrolled medical centers who are undergoing clinically indicated bronchoscopy for suspect lung cancer and who are current or former cigarette smokers.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746759

  Show 21 Study Locations
Sponsors and Collaborators
Allegro Diagnostics, Corp.
University of Pennsylvania
Columbia University
Temple University
Indiana University
University of Alabama at Birmingham
University of Missouri-Columbia
Louisiana State University Health Sciences Center in New Orleans
University of Wisconsin, Madison
Medical University of South Carolina
National Jewish Health
Overlake Hospital Bellevue WA
Pulmonary and Allergy Associates of New Jersey
Pulmonary Associates of Arizona
William Jennings Bryan Dorn VA Medical Center
Virginia Commonwealth University
Jamaica Hospital Medical Center
North Florida/South Georgia Veterans Health System
Steward St. Elizabeth's Medical Center of Boston, Inc.
University of California, Davis
Yale University
The Cleveland Clinic
Investigators
Study Director: Duncan Whitney, PhD Allegro Diagnostics
  More Information

Additional Information:
No publications provided

Responsible Party: Allegro Diagnostics, Corp.
ClinicalTrials.gov Identifier: NCT00746759     History of Changes
Other Study ID Numbers: ADx-0001: IDE G090194
Study First Received: September 3, 2008
Last Updated: July 10, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Allegro Diagnostics, Corp.:
Lung Cancer
Smoker
Former Smoker
Gene Expression
Bronchoscopy

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 23, 2014