Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-31 @ 1:57 PM
Study NCT ID:
NCT05389956
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2022-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification of Risk Factors for Cardiovascular Disease and Cancer in Korean Population: A Prospective Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 510000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2052-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-18', 'studyFirstSubmitDate': '2022-05-21', 'studyFirstSubmitQcDate': '2022-05-21', 'lastUpdatePostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2042-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major adverse cardiovascular event (MACE)', 'timeFrame': '10 year', 'description': 'A major adverse cardiovascular event (MACE) of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke'}, {'measure': 'Incidence of malignancy', 'timeFrame': '10 year', 'description': 'The occurrence of any malignancy of interest'}], 'secondaryOutcomes': [{'measure': 'All-cause death', 'timeFrame': '10 year'}, {'measure': 'Cardiovascular death', 'timeFrame': '10 year'}, {'measure': 'Myocardial infarction', 'timeFrame': '10 year'}, {'measure': 'Stroke', 'timeFrame': '10 year'}, {'measure': 'Cancer related mortality', 'timeFrame': '10 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiovascular disease', 'Malignancy', 'Risk factor'], 'conditions': ['Cardiovascular Diseases', 'Malignancy', 'Risk Factor']}, 'descriptionModule': {'briefSummary': 'Cancer and cardiovascular disease are the global leading causes of death. These two disease entities are multifactorial disease that are caused by several factors. The aim of this prospective cohort study was to investigate the status of risk factors profiles and health related behavior in Korean population, and to discover novel risk factors associated with the occurrence of endpoint events.', 'detailedDescription': 'This is a single center, observational, prospective cohort study. The primary outcomes include the incidence of MACE (major adverse cardiovascular events) and the incidence of any malignancy. We plan to collect the baseline information at enrollment and the occurrence of clinical endpoint events will be followed for at least 10 years. The study will enroll 510,000 subjects aged ≥19 years who underwent a general health screening in Korea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Health screening participants aged 19 years and older from community and workplace', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women aged 19 years and older who underwent a general health screening at the health promotion center of Ulsan University Hospital (Ulsan, Korea)\n* Subjects have to agree to participate by signing a consent\n\nExclusion Criteria:\n\n* Subjects who cannot or reject to sign the consent form.'}, 'identificationModule': {'nctId': 'NCT05389956', 'briefTitle': 'Identification of Risk Factors for Cardiovascular Disease and Cancer in Korean Population: A Prospective Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Ulsan University Hospital'}, 'officialTitle': 'Identification of Risk Factors for Cardiovascular Disease and Cancer in Korean Population: A Prospective Cohort Study', 'orgStudyIdInfo': {'id': '2021-12-014-003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ulsan University Hospital-Health Screening Cohort (UUH-HEALS)', 'description': 'Ulsan University Hospital-Health Screening Cohort is a prospective cohort of participants who participated in general health screening programs at the Health Promotion Center of Ulsan University Hospital (Ulsan, South Korea). This cohort includes health screening participants aged 19 years and older from community and workplace. The purpose of this cohort is to offer relevant and useful data on health risk factors in the field of non-communicable diseases such as cardiovascular disease and malignancy.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44033', 'city': 'Ulsan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sangwoo Park, MD', 'role': 'CONTACT', 'email': 'warya7@naver.com'}, {'name': 'Sangwoo Park, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ulsan University Hospital', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}], 'centralContacts': [{'name': 'Sangwoo Park, MD', 'role': 'CONTACT', 'email': 'warya7@naver.com', 'phone': '82-52-250-8669'}], 'overallOfficials': [{'name': 'Sangwoo Park, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ulsan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ulsan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Sangwoo Park', 'investigatorAffiliation': 'Ulsan University Hospital'}}}}