Lung CancerAEGIS IDENCT00746759
Airway Epithelium Gene Expression: AEGIS IDE
An observational study of Lung Cancer, run by Allegro Diagnostics, Corp. at 21 sites in United States.
Trial summary
The purpose of the research study is to develop a new, more sensitive, and less invasive test for diagnosing lung cancer at an earlier stage, when it can more easily be cured. The investigators hypothesize that certain genes are expressed differently in current and former smokers who have lung cancer, and this… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Biomarker (not used as an intervention)
- Type of treatment
- Medical device
- How many people
- 1,331 participants
- Where
- 21 sitesUnited States
- Study dates
- Feb 2010to Feb 2015
- 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 of enrolled medical centers who are undergoing clinically indicated bronchoscopy for suspect lung cancer and who are current or former cigarette smokers.
Who may be able to join
- Patients being evaluated for the diagnosis of possible lung cancer or "rule out lung cancer" and undergoing clinically indicated bronchoscopy
- All patients are required to be at least 21 years of age and be able to understand and sign the informed consent form
- Patient must be a current or former cigarette smoker
Who cannot join
- A pulmonary physician does not recommend that bronchoscopy be performed
- Inability to understand the written consent form and comply with requirements of the study
- History of prior primary lung cancer
- Immediately prior to bronchoscopy, the patient has been on a mechanical ventilator for >24 consecutive hours.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Overlake Hospital
Bellevue, Washington, 98004
University of Alabama
Birmingham, Alabama, 35294
St. Elizabeth's Medical Center
Boston, Massachusetts, 02135
Medical University of South Carolina
Charleston, South Carolina, 29425
Cleveland Clinic
Cleveland, Ohio
University of Missouri
Columbia, Missouri, 65203
Dorn VA
Columbia, South Carolina, 29209
National Jewish Health
Denver, Colorado, 80206
North Florida/South Georgia VA
Gainesville, Florida, 32608
Indiana University
Indianapolis, Indiana, 46202
Jamaica Hospital Medical Center
Jamaica, New York, 11418
University of Wisconsin
Madison, Wisconsin, 53792
Yale Univeristy
New Haven, Connecticut
LSU
New Orleans, Louisiana, 70112
Columbia University
New York, New York, 10032
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Temple University
Philadelphia, Pennsylvania, 19140
Pulmonary Associates of Arizona
Phoenix, Arizona, 85006
Virginia Commonwealth University
Richmond, Virginia, 23298
University of California- Davis
Sacramento, California
Pulmonary and Allergy Associates of New Jersey
Summit, New Jersey, 07901
About this study
Official title: Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer: AEGIS IDE
The purpose of the research study is to develop a new, more sensitive, and less invasive test for diagnosing lung cancer at an earlier stage, when it can more easily be cured. The investigators hypothesize that certain genes are expressed differently in current and former smokers who have lung cancer, and this difference in gene expression may be a biomarker for lung cancer.
Read the detailed description
Allegro Diagnostics is funding this multi-center study to validate and extend a new diagnostic tool measuring global gene expression in airway epithelial cells obtained at routine bronchoscopy in suspect lung cancer patients. The test, which is highly sensitive and specific for lung cancer, measures the levels of expression of genes in cells brushed from the large bronchi during diagnostic bronchoscopy. Similar brushings of epithelial cells from the nose will be analyzed to determine if gene expression in these cells can be used as a screening tool in subjects who may have now or be at risk for developing lung cancer in the future.
- Conditions
- Lung Cancer
- Being tested
- Biomarker (not used as an intervention)
- Keywords
- Lung Cancer, Smoker, Former Smoker, Gene Expression, Bronchoscopy
- Medical subject headings
- Lung Neoplasms, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker (not used as an intervention)Device
Also called BronchoGen
This study is an observational study. There is no intervention.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Not described Receives: Device: Biomarker (not used as an intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Cancer Diagnosis (positive or negative)
Patients may be followed at 12 months post bronchoscopy to finalize diagnosis if diagnosis had not previously been confirmed. The biomarker score will be compared to the standard diagnosis to evaluate the sensitivity, specificity, and negative predictive values of the biomarker.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2008 (estimated)
- Study startFeb 2010
- Primary completionDec 2014
- Study completionFeb 2015
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
- 1,331 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allegro Diagnostics, Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania, Columbia University, Temple University, Indiana University, University of Alabama at Birmingham, University of Missouri-Columbia, Louisiana State University Health Sciences Center in New Orleans, University of Wisconsin, Madison, Medical University of South Carolina, National Jewish Health, Overlake Hospital Bellevue WA, Pulmonary and Allergy Associates of New Jersey, Pulmonary Associates of Arizona, William Jennings Bryan Dorn VA Medical Center, Virginia Commonwealth University, Jamaica Hospital Medical Center, North Florida/South Georgia Veterans Health System, Steward St. Elizabeth's Medical Center of Boston, Inc., University of California, Davis, Yale University, The Cleveland Clinic
- Responsible party
- Sponsor
- Investigators
- Duncan Whitney, PhD, Study director, Allegro Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746759
- Sponsor's protocol ID
- ADx-0001: IDE G090194
- Acronym
- AEGIS IDE
- Status last verified
- Jun 2015
- First submitted
- 3 Sep 2008
- Last updated
- 4 Jun 2015
- 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 4 Jun 2015. 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 IDE
- ClinicalTrials.gov ID
- NCT00746759
- Acronym / sponsor ID
- AEGIS IDE / ADx-0001: IDE G090194
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer, Smoker, Former Smoker, Gene Expression, Bronchoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,331 participants (actual)
- Lead sponsor
- Allegro Diagnostics, Corp.Industry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania, Columbia University, Temple University, Indiana University, University of Alabama at Birmingham, University of Missouri-Columbia, Louisiana State University Health Sciences Center in New Orleans, University of Wisconsin, Madison, Medical University of South Carolina, National Jewish Health, Overlake Hospital Bellevue WA, Pulmonary and Allergy Associates of New Jersey, Pulmonary Associates of Arizona, William Jennings Bryan Dorn VA Medical Center, Virginia Commonwealth University, Jamaica Hospital Medical Center, North Florida/South Georgia Veterans Health System, Steward St. Elizabeth's Medical Center of Boston, Inc., University of California, Davis, Yale University, The Cleveland Clinic
- Study start
- Feb 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 4 Sep 2008 (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 purpose of the research study is to develop a new, more sensitive, and less invasive test for diagnosing lung cancer at an earlier stage, when it can more easily be cured. The investigators hypothesize that certain genes are expressed differently in current and former smokers who have lung cancer, and this difference in gene expression may be a biomarker for lung cancer.
Detailed description
Allegro Diagnostics is funding this multi-center study to validate and extend a new diagnostic tool measuring global gene expression in airway epithelial cells obtained at routine bronchoscopy in suspect lung cancer patients. The test, which is highly sensitive and specific for lung cancer, measures the levels of expression of genes in cells brushed from the large bronchi during diagnostic bronchoscopy. Similar brushings of epithelial cells from the nose will be analyzed to determine if gene expression in these cells can be used as a screening tool in subjects who may have now or be at risk for developing lung cancer in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | – | Device: Biomarker (not used as an intervention) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of enrolled medical centers who are undergoing clinically indicated bronchoscopy for suspect lung cancer and who are current or former cigarette smokers.
Key inclusion criteria (3 listed)
- Patients being evaluated for the diagnosis of possible lung cancer or "rule out lung cancer" and undergoing clinically indicated bronchoscopy
- All patients are required to be at least 21 years of age and be able to understand and sign the informed consent form
- Patient must be a current or former cigarette smoker
Key exclusion criteria (4 listed)
- A pulmonary physician does not recommend that bronchoscopy be performed
- Inability to understand the written consent form and comply with requirements of the study
- History of prior 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomarker (not used as an intervention)Also: BronchoGenThis study is an observational study. There is no intervention. | Device | Standard of Care |
Primary outcome
Lung Cancer Diagnosis (positive or negative)
Time frame: 12 months
Patients may be followed at 12 months post bronchoscopy to finalize diagnosis if diagnosis had not previously been confirmed. The biomarker score will be compared to the standard diagnosis to evaluate the sensitivity, specificity, and negative predictive values of the biomarker.
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 4 Jun 2015.
- 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
21 sites in 1 country: 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 21 sites in United States.
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 3 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 4 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. 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?
Lung Cancer Diagnosis (positive or negative) (time frame: 12 months). 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 NCT00746759, 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 4 Jun 2015.