Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-30 @ 12:31 AM
Study NCT ID:
NCT00814203
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
2008-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Registry of COPD Patients to be Used for Future Studies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-28', 'studyFirstSubmitDate': '2008-12-23', 'studyFirstSubmitQcDate': '2008-12-23', 'lastUpdatePostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'This is a registry protocol to determine factors contributing to the development of chronic obstructive lung disease.'}], 'secondaryOutcomes': [{'measure': 'To develop a repository of blood from subjects with COPD for future studies. These studies may include evaluation of biologic markers of disease severity and progression.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD'], 'conditions': ['Chronic Obstructive Lung Disease']}, 'descriptionModule': {'briefSummary': 'To develop a cohort of COPD participants to assist study staff in determining the most likely candidates for future studies.', 'detailedDescription': 'To develop a cohort of COPD participants for study staff to determine the most likely candidates for future studies and to develop a repository of blood from subjects with COPD for future studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'primary care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are 18 years of age and older who have been diagnosed with COPD by at least one of the following:\n\n * clinical history-a documented history of COPD, emphysema, or chronic bronchitis;\n * pulmonary function results (defined as an FEV1/FVC less than 0.7;\n * radiographic results (high-resolution CT findings of emphysema\n\nExclusion Criteria:\n\n* in ability to give informed consent\n* prisoners\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT00814203', 'briefTitle': 'A Registry of COPD Patients to be Used for Future Studies', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'The Ohio State University COPD Registry', 'orgStudyIdInfo': {'id': '2007H0248'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic obstructive lung disease', 'description': 'those with a condition'}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Philip Diaz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philip Diaz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Philip Diaz M.D.', 'investigatorFullName': 'Philip Diaz', 'investigatorAffiliation': 'Ohio State University'}}}}