Lung CancerAEGISNCT01309087
Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer: AEGIS CLIA
An observational study of Lung Cancer, run by Allegro Diagnostics, Corp. at 14 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 756 participants
- Where
- 14 sitesin 3 countries
- Study dates
- Jan 2009to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are undergoing clinically indicated bronchoscopy for rule out lung cancre and have a history of cigarette smoking
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
United States12 sites
Georgia Lung Associates
Austell, Georgia, 30106
University of Alabama
Birmingham, Alabama, 35294
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of Virginia
Charlottesville, Virginia, 22908
University of Missouri
Columbia, Missouri, 65203
Indiana University
Indianapolis, Indiana, 46202
Vanderbilt University
Nashville, Tennessee, 37232
LSU
New Orleans, Louisiana, 70112
New York University
New York, New York, 10016
Columbia University
New York, New York, 10032
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Temple University
Philadelphia, Pennsylvania, 19140
About this study
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.
- Conditions
- Lung Cancer
- Keywords
- Gene Expression, Lung Cancer, Smoking
- Medical subject headings
- Lung Neoplasms, Smoking
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Lung Cancer
Measured: One year from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
- Study startJan 2009
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 756 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allegro Diagnostics, Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- 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
- Investigators
- Duncan Whitney, PhD, Study director, Allegro Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01309087
- Sponsor's protocol ID
- ADx-0001: AEGIS CLIA
- Acronym
- AEGIS
- Status last verified
- Mar 2014
- First submitted
- 3 Mar 2011
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
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 26896702Silvestri 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer: AEGIS CLIA
- ClinicalTrials.gov ID
- NCT01309087
- Acronym / sponsor ID
- AEGIS / ADx-0001: AEGIS CLIA
- Conditions
- Lung Cancer
- Keywords
- Gene Expression, Lung Cancer, Smoking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 756 participants (actual)
- Lead sponsor
- Allegro Diagnostics, Corp.Industry (pharma, biotech, devices)
- 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
- Study start
- Jan 2009
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 4 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are undergoing clinically indicated bronchoscopy for rule out lung cancre and have a history of cigarette smoking
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary Lung Cancer
Time frame: One year from enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
- Derived from this study: PubMed 26896702Vachani 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.
- Derived from this study: PubMed 25981554Silvestri 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duncan Whitney, PhD study director
Allegro Diagnostics
14 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Allegro Diagnostics, Corp. at 14 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Canada, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Lung Cancer (time frame: One year from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01309087, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2014.