Ignite Creation Date:
2025-12-24 @ 12:39 PM
Ignite Modification Date:
2026-03-28 @ 10:01 AM
Study NCT ID:
NCT02076061
Status:
COMPLETED
Last Update Posted:
2022-08-24
First Post:
2014-02-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers of Early Chronic Obstructive Pulmonary Disease (COPD) in Smokers - Longitudinal Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], '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'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015438', 'term': 'Health Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-23', 'studyFirstSubmitDate': '2014-02-27', 'studyFirstSubmitQcDate': '2014-02-27', 'lastUpdatePostDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Advanced disease etiology requiring hospitalization.', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD', 'Primary Care', 'Smoking', 'Smokers', 'ex-Smokers', 'Lung Cancer', 'Cardiovascular Disease', 'Proteomics', 'Biomarkers', 'Biobank', 'Disease Staging', 'Gold Stage'], 'conditions': ['Chronic Obstructive Pulmonary Disease', 'Cardiovascular Disease', 'Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This is a longitudinal observational study to identify and validate protein biomarkers for COPD (chronic obstructive pulmonary diseases) and cardiovascular disease in smokers and ex-smokers attending primary care. Special emphasize is to correlate biomarkers to different phases of COPD, to progression of the disease, and to treatment of the disease. Furthermore, linkage between COPD, cardiovascular disease, and lung cancer will be investigated by identifying protein biomarkers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinic in Malmö, Sweden', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDiagnosed with COPD Gold stage 0-IV\n\nExclusion Criteria:\n\nPatients with inflammatory diseases Patients with cancer Patients using immune system regulating drugs'}, 'identificationModule': {'nctId': 'NCT02076061', 'briefTitle': 'Biomarkers of Early Chronic Obstructive Pulmonary Disease (COPD) in Smokers - Longitudinal Study', 'organization': {'class': 'OTHER', 'fullName': 'Lund University'}, 'officialTitle': 'Biomarkers of Early Chronic Obstructive Pulmonary Disease (COPD) and Cardiovascular Diseases in Smokers/Ex-Smokers Attending Primary Care - Longitudinal Study', 'orgStudyIdInfo': {'id': 'KOL 001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GOLD stage I'}, {'label': 'GOLD Stage II'}, {'label': 'GOLD Stage III'}, {'label': 'GOLD Stage IV'}, {'label': 'Smokers/ex-smokers w/o COPD'}, {'label': 'non-Smokers w/o COPD'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Malmo', 'country': 'Sweden', 'facility': 'Örestadskliniken', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}], 'overallOfficials': [{'name': 'Johan Malm', 'role': 'STUDY_CHAIR', 'affiliation': 'Clincal Chemistry, Lund University'}, {'name': 'György Marko-Varga', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Protein Science & Imaging, Lund University'}, {'name': 'Mikael Truedsson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Örestadskliniken Malmö'}, {'name': 'Elisabet Wieslander', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Oncology and Pathology, Lund University'}, {'name': 'Thomas E Fehniger', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Protein Science & Imaging, Lund University'}, {'name': 'Magnus Dahlbäck', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Protein Science & Imaging, Lund University'}, {'name': 'Roger Appelqvist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Protein Science & Imaging, Lund University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lund University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Örestadskliniken', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Clincal Chemistry', 'investigatorFullName': 'Johan Malm', 'investigatorAffiliation': 'Lund University'}}}}