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CompletedNCT01309087AEGISUpdated Mar 26, 2014

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

An observational study in Lung Cancer, sponsored by Allegro Diagnostics, Corp.. Completed at 14 sites in 3 countries. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2014-03-26.

Sponsored by Allegro Diagnostics, Corp. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
756
Ages
21 Years and older
Sex
All
01

Study summary

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.

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Conditions studied

  • Lung Cancer

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Keywords

  • Gene Expression
  • Lung Cancer
  • Smoking
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 756 is above the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Allegro Diagnostics, Corp. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
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

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
756 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Primary Lung Cancer

    Time frame: One year from enrollment

07

Study locations

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

Publications

  • Vachani A, Whitney DH, Parsons EC, Lenburg M, Ferguson JS, Silvestri GA, Spira A. Clinical Utility of a Bronchial Genomic Classifier in Patients With Suspected Lung Cancer. Chest. 2016 Jul;150(1):210-8. doi: 10.1016/j.chest.2016.02.636. Epub 2016 Feb 16. PubMed 26896702 ↗
  • Silvestri GA, Vachani A, Whitney D, Elashoff M, Porta Smith K, Ferguson JS, Parsons E, Mitra N, Brody J, Lenburg ME, Spira A; AEGIS Study Team. A Bronchial Genomic Classifier for the Diagnostic Evaluation of Lung Cancer. N Engl J Med. 2015 Jul 16;373(3):243-51. doi: 10.1056/NEJMoa1504601. Epub 2015 May 17. PubMed 25981554 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01309087
Lead sponsor
Allegro Diagnostics, Corp.
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 PC
Responsible party
Sponsor
First posted
Mar 4, 2011
Start date
Jan 2009
Primary completion
May 2013
Completion
May 2013
Last update
Mar 26, 2014

Study contacts

Duncan Whitney, PhD
study director · Allegro Diagnostics

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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