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

March 24, 2014 updated by: Allegro Diagnostics, Corp.
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

756

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • University of British Columbia
  • Ireland
      • Dublin, Ireland, 8
        • Trinity College
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama
    • Georgia
      • Austell, Georgia, United States, 30106
        • Georgia Lung Associates
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • LSU
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Missouri
      • Columbia, Missouri, United States, 65203
        • University of Missouri
    • New York
      • New York, New York, United States, 10032
        • Columbia University
      • New York, New York, United States, 10016
        • New York University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary Lung Cancer
Time Frame: One year from enrollment
One year from enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allegro Diagnostics, Corp.

Collaborators

University of Missouri-Columbia
University of Pennsylvania
University of British Columbia
Beth Israel Deaconess Medical Center
University of Alabama at Birmingham
New York University
Columbia University
Vanderbilt University
Temple University
University of Virginia
Indiana University
Louisiana State University Health Sciences Center in New Orleans
University of Dublin, Trinity College
Georgia Lung Associates PC

Investigators

  • Study Director: Duncan Whitney, PhD, Allegro Diagnostics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

March 3, 2011

First Submitted That Met QC Criteria

March 3, 2011

First Posted (Estimate)

March 4, 2011

Study Record Updates

Last Update Posted (Estimate)

March 26, 2014

Last Update Submitted That Met QC Criteria

March 24, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADx-0001: AEGIS CLIA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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