Ignite Creation Date:
2025-12-24 @ 2:34 PM
Ignite Modification Date:
2026-03-07 @ 9:30 PM
Study NCT ID:
NCT00746759
Status:
COMPLETED
Last Update Posted:
2015-06-04
First Post:
2008-09-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Airway Epithelium Gene Expression: AEGIS IDE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Cells, Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1331}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-02', 'studyFirstSubmitDate': '2008-09-03', 'studyFirstSubmitQcDate': '2008-09-03', 'lastUpdatePostDateStruct': {'date': '2015-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lung Cancer Diagnosis (positive or negative)', 'timeFrame': '12 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lung Cancer', 'Smoker', 'Former Smoker', 'Gene Expression', 'Bronchoscopy'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '26896702', 'type': 'DERIVED', 'citation': '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': '25981554', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of enrolled medical centers who are undergoing clinically indicated bronchoscopy for suspect lung cancer and who are current or former cigarette smokers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients being evaluated for the diagnosis of possible lung cancer or "rule out lung cancer" and undergoing clinically indicated bronchoscopy\n* All patients are required to be at least 21 years of age and be able to understand and sign the informed consent form\n* Patient must be a current or former cigarette smoker\n\nExclusion Criteria:\n\n* A pulmonary physician does not recommend that bronchoscopy be performed\n* Inability to understand the written consent form and comply with requirements of the study\n* History of prior primary lung cancer\n* Immediately prior to bronchoscopy, the patient has been on a mechanical ventilator for \\>24 consecutive hours.'}, 'identificationModule': {'nctId': 'NCT00746759', 'acronym': 'AEGIS IDE', 'briefTitle': 'Airway Epithelium Gene Expression: AEGIS IDE', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allegro Diagnostics, Corp.'}, 'officialTitle': 'Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer: AEGIS IDE', 'orgStudyIdInfo': {'id': 'ADx-0001: IDE G090194'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Standard of Care', 'interventionNames': ['Device: Biomarker (not used as an intervention)']}], 'interventions': [{'name': 'Biomarker (not used as an intervention)', 'type': 'DEVICE', 'otherNames': ['BronchoGen'], 'description': 'This study is an observational study. There is no intervention.', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pulmonary Associates of Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California- Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '80206', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'National Jewish Health', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Univeristy', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'North Florida/South Georgia VA', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'LSU', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02135', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "St. Elizabeth's Medical Center", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '65203', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '07901', 'city': 'Summit', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Pulmonary and Allergy Associates of New Jersey', 'geoPoint': {'lat': 40.71562, 'lon': -74.36468}}, {'zip': '11418', 'city': 'Jamaica', 'state': 'New York', 'country': 'United States', 'facility': 'Jamaica Hospital Medical Center', 'geoPoint': {'lat': 40.69149, 'lon': -73.80569}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29209', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Dorn VA', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98004', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'Overlake Hospital', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Duncan Whitney, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allegro Diagnostics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allegro Diagnostics, Corp.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Pennsylvania', 'class': 'OTHER'}, {'name': 'Columbia University', 'class': 'OTHER'}, {'name': 'Temple University', 'class': 'OTHER'}, {'name': 'Indiana University', 'class': 'OTHER'}, {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, {'name': 'University of Missouri-Columbia', 'class': 'OTHER'}, {'name': 'Louisiana State University Health Sciences Center in New Orleans', 'class': 'OTHER'}, {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, {'name': 'National Jewish Health', 'class': 'OTHER'}, {'name': 'Overlake Hospital Bellevue WA', 'class': 'UNKNOWN'}, {'name': 'Pulmonary and Allergy Associates of New Jersey', 'class': 'UNKNOWN'}, {'name': 'Pulmonary Associates of Arizona', 'class': 'UNKNOWN'}, {'name': 'William Jennings Bryan Dorn VA Medical Center', 'class': 'FED'}, {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, {'name': 'Jamaica Hospital Medical Center', 'class': 'OTHER'}, {'name': 'North Florida/South Georgia Veterans Health System', 'class': 'OTHER'}, {'name': "Steward St. Elizabeth's Medical Center of Boston, Inc.", 'class': 'OTHER'}, {'name': 'University of California, Davis', 'class': 'OTHER'}, {'name': 'Yale University', 'class': 'OTHER'}, {'name': 'The Cleveland Clinic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}