NCT01309087

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
756

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
3 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

March 26, 2014

Status Verified

March 1, 2014

Enrollment Period

4.3 years

First QC Date

March 3, 2011

Last Update Submit

March 24, 2014

Conditions

Lung Cancer

Keywords

Gene ExpressionLung CancerSmoking

Outcome Measures

Primary Outcomes (1)

  • Primary Lung Cancer

    One year from enrollment

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are undergoing clinically indicated bronchoscopy for rule out lung cancre and have a history of cigarette smoking

You may qualify if:

  • The patient is being evaluated for the diagnosis of possible lung cancer or "rule out lung cancer" and is indicated for bronchoscopy.
  • The patient is undergoing bronchoscopy
  • ≥ 21 years of age
  • Patient meets local site's standard of care (SOC) for performing diagnostic bronchoscopy
  • The patient is a current or former cigarette smoker (defined as having smoked \>100 cigarettes in their lifetime.

You may not qualify if:

  • The Pulmonary physician does not recommend that bronchoscopy be performed
  • The patient is unable to be consented into the study or unable to comply with requirements of the study
  • The patient has previously been diagnosed with primary lung cancer
  • Immediately prior to bronchoscopy, the patient has been on a mechanical ventilator for ≥ 24 consecutive hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

Georgia Lung Associates

Austell, Georgia, 30106, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

LSU

New Orleans, Louisiana, 70112, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Missouri

Columbia, Missouri, 65203, United States

Location

New York University

New York, New York, 10016, United States

Location

Columbia University

New York, New York, 10032, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

University of British Columbia

Vancouver, British Columbia, Canada

Location

Trinity College

Dublin, 8, Ireland

Location

Related Publications (2)

  • 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.

    PMID: 26896702DERIVED

  • 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.

    PMID: 25981554DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Cells, Blood

MeSH Terms

Conditions

Lung NeoplasmsSmoking

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesBehavior

Study Officials

  • Duncan Whitney, PhD

    Allegro Diagnostics

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2011

First Posted

March 4, 2011

Study Start

January 1, 2009

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

March 26, 2014

Record last verified: 2014-03

Locations

US(12)CA(1)IE(1)