Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Columbia University
Vanderbilt University
University of British Columbia
University of Pennsylvania
New York University
Temple University
Indiana University
University of Alabama at Birmingham
University of Virginia
University of Missouri-Columbia
Louisiana State University Health Sciences Center in New Orleans
University of Dublin, Trinity College
Georgia Lung Associates
Information provided by (Responsible Party):
Allegro Diagnostics, Corp.
ClinicalTrials.gov Identifier:
NCT01309087
First received: March 3, 2011
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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.


Condition
Lung Cancer

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Primary Lung Cancer [ Time Frame: One year from enrollment ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Cells, Blood


Enrollment: 756
Study Start Date: January 2009
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
  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 who are undergoing clinically indicated bronchoscopy for rule out lung cancre and have a history of cigarette smoking

Criteria

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.
  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: NCT01309087

Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294
United States, Georgia
Georgia Lung Associates
Austell, Georgia, United States, 30106
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Louisiana
LSU
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65203
United States, New York
Columbia University
New York, New York, United States, 10032
New York University
New York, New York, United States, 10016
United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19140
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada
Ireland
Trinity College
Dublin, Ireland, 8
Sponsors and Collaborators
Allegro Diagnostics, Corp.
Beth Israel Deaconess Medical Center
Columbia University
Vanderbilt University
University of British Columbia
University of Pennsylvania
New York University
Temple University
Indiana University
University of Alabama at Birmingham
University of Virginia
University of Missouri-Columbia
Louisiana State University Health Sciences Center in New Orleans
University of Dublin, Trinity College
Georgia Lung Associates
Investigators
Study Director: Duncan Whitney, PhD Allegro Diagnostics
  More Information

No publications provided

Responsible Party: Allegro Diagnostics, Corp.
ClinicalTrials.gov Identifier: NCT01309087     History of Changes
Other Study ID Numbers: ADx-0001: AEGIS CLIA
Study First Received: March 3, 2011
Last Updated: March 24, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board
Canada: Ethics Review Committee

Keywords provided by Allegro Diagnostics, Corp.:
Gene Expression
Lung Cancer
Smoking

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

ClinicalTrials.gov processed this record on November 25, 2014