Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT02183818
Status:
COMPLETED
Last Update Posted:
2021-05-28
First Post:
2014-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Integrative-omics of the Disordered COPD Small Airway Epithelium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-26', 'studyFirstSubmitDate': '2014-06-17', 'studyFirstSubmitQcDate': '2014-07-02', 'lastUpdatePostDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of network pressure points relevant to SAE biology confirmed by analyze of SAE data sets.', 'timeFrame': 'One Year', 'description': 'Using an integrated network systems approach to analyze our extensive existing SAE omic data sets at the genetic, epigenetic (methylation), gene expression, microRNA and metabolomics levels, to develop an initial model of network connectivities and key network pressure points relevant to SAE biology in health and disease.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Smoking', 'COPD', 'Non-Smokers', 'Smokers'], 'conditions': ['Smoking', 'COPD']}, 'descriptionModule': {'briefSummary': 'We aim to use an integrated network systems approach to analyze certain existing small airway epithelium (SAE) omic data sets at the genetic, epigenetic (methylation), gene expression, microRNA and metabolomic levels, to develop an initial model of network connectivities and key network pressure points relevant to SAE biology in health and disease.', 'detailedDescription': 'Hypothesis: We hypothesize that the disordered differentiation of the SAE that characterizes COPD results from the complex interaction of cigarette smoke components with a hierarchy of genetic, epigenetic, gene expression and metabolomics network interactions as the BC differentiate into a mucociliary epithelium.\n\nSpecific aim 1. Using an integrated network systems approach to analyze our extensive existing SAE omic data sets at the genetic, epigenetic (methylation), gene expression, microRNA and metabolomics levels, to develop an initial model of network connectivities and key network pressure points relevant to SAE biology in health and disease.\n\nSpecific aim 2. To refine the model, a comprehensive omics data set will be collected at multiple time points as SAE BC of nonsmokers and COPD smokers differentiate to normal and disordered mucociliary epithelium (respectively) on air-liquid interface (ALI) culture, an in vitro model of SAE differentiation. The computational strategies from aim 1 will be used to improve the model with these data.\n\nSpecific aim 3. To test and finalize the integrated network model, a parallel omics data set will be generated from BC from nonsmokers, and COPD smokers as they differentiate on ALI under conditions where key hubs will be up- or down-regulated and the differentiation process stressed under conditions mimicking the in vivo SAE environment. The end result will be an integrated systems model of SAE biology and how this is disordered in COPD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'New York Metropolitan Area residents', 'healthyVolunteers': True, 'eligibilityCriteria': 'Healthy nonsmokers (n=50)\n\nInclusion criteria\n\n* Must be enrolled into IRB approved protocol #1204012331(all inclusion criteria from protocol #1204012331 thus applies to this protocol)\n* Self-reported never-smokers, with current smoking status validated by the absence of nicotine metabolites in urine (nicotine less than 2 ng/ml and cotinine less than 5 ng/ml)\n* Negative HIV serology\n\nSmokers with COPD (n=50)\n\nInclusion criteria\n\n* Must be enrolled into IRB approved protocol #1204012331(all inclusion criteria from protocol #1204012331 thus applies to this protocol)\n* Self-reported current daily smokers with greater than or equal to 10 pack-yr, validated by any of the following: urine nicotine greater than 30 ng/ml or urine cotinine greater than 50 ng/ml\n* Meeting GOLD stages I-III criteria for chronic obstructive lung disease (COPD) based on postbronchodilator spirometry\n* Taking any or no pulmonary-related medication, including beta-agonists, anticholinergics, or inhaled corticosteroids\n* Negative HIV serology\n\nHealthy nonsmokers (n=50)\n\nExclusion criteria\n\n* Unable to meet the inclusion criteria (all exclusion criteria from protocol #1204012331 applies to this protocol)\n* Evidence of malignancy within the past 5 years\n\nSmokers with COPD (n=50)\n\nExclusion criteria\n\n* Unable to meet the inclusion criteria (all exclusion criteria from protocol #1204012331 applies to this protocol)\n* Individuals in whom participation in the study would compromise the normal care and expected progression of their disease\n* Evidence of malignancy within the past 5 years'}, 'identificationModule': {'nctId': 'NCT02183818', 'briefTitle': 'Integrative-omics of the Disordered COPD Small Airway Epithelium', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'Integrative-omics of the Disordered COPD Small Airway Epithelium', 'orgStudyIdInfo': {'id': '1301013416'}, 'secondaryIdInfos': [{'id': 'R01HL118541', 'link': 'https://reporter.nih.gov/quickSearch/R01HL118541', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy nonsmokers', 'description': 'Physical assessment, EKG, blood and urine draw, chest x-ray, pulmonary function test (PFT), and bronchoscopy'}, {'label': 'Smokers with COPD', 'description': 'Physical assessment, EKG, blood and urine draw, chest x-ray, pulmonary function test (PFT), and bronchoscopy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical College', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Ronald G Crystal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}