Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-01-08 @ 10:59 AM
Study NCT ID:
NCT03288805
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-05-05
First Post:
2017-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cohort Study in South China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002908', 'term': 'Chronic Disease'}], 'ancestors': [{'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': 'Serum ,Urine and fecal samples for biochemical tests, biomarker examination and DNA extraction'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-03', 'studyFirstSubmitDate': '2017-09-18', 'studyFirstSubmitQcDate': '2017-09-18', 'lastUpdatePostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of chronic disease', 'timeFrame': '4 years', 'description': 'Incidence of chronic disease, including stroke, coronary heart disease, cancer, chronic obstructive pulmonary disease, diabetes and hypertension'}], 'secondaryOutcomes': [{'measure': 'Risk factors for chronic diseases', 'timeFrame': '4 years', 'description': 'Incidence of impaired glucose tolerance and obesity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Disease']}, 'descriptionModule': {'briefSummary': 'Healthy Chinese residents from South China will be recruited and followed up for at least 4 years to evaluate the association between climate, diet and lifestyle and risks for the development of chronic diseases. Physical examination, questionnaire survey and biological sample collection will be conducted at baseline and the incidence of chronic diseases will be investigated during follow-up.', 'detailedDescription': '110,000 adult Chinese (35 to 74 years old) without chronic diseases and major disability who have been living in South China including Guangdong, Fujian, Guangxi and Hainan for more than 5 years will be recruited. All participants will be prospectively followed up for the incidence of chronic diseases (stroke, coronary heart disease, malignant neoplasms, chronic obstructive pulmonary diseases, diabetes and hypertension) and their risk factors (impaired glucose tolerance and obesity). Information about socio-demographic, diet, lifestyle, psychological status, medical history and current medication will be collected by questionnaires. Physical examinations including height, weight, waist and hip circumferences, blood pressure, fat mass and vital capacity will be conducted. Besides, blood, urine and fecal samples will be collected for further analysis. Annual meteorological data throughout the study period will also be collected. The associations between climate, diet and lifestyle and risks for chronic diseases will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult Chinese (35-74 years old) who have been living in South China including Guangdong, Fujian, Guangxi and Hainan provinces for more than 5 years.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult Chinese (35-74 years old) who have been living in South China including Guangdong, Fujian, Guangxi and Hainan provinces for more than 5 years.\n\nExclusion Criteria:\n\n* any subject diagnosed with stroke, coronary heart disease, malignancy, chronic obstructive pulmonary disease, diabetes and hypertension.\n* any subject who suffer from major disability and cannot participate in the study.'}, 'identificationModule': {'nctId': 'NCT03288805', 'briefTitle': 'Cohort Study in South China', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Prospective Cohort Study of Chronic Diseases in South China', 'orgStudyIdInfo': {'id': '2017YFC0907100'}}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-Sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Min Xia', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Public Health,Nutrition and Food Hygiene,Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Min Xia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Guangxi Medical University', 'class': 'OTHER'}, {'name': 'Hainan Medical College', 'class': 'OTHER'}, {'name': "Guangzhou No.12 People's Hospital", 'class': 'OTHER_GOV'}, {'name': 'Fujian Medical University', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Xiamen University', 'class': 'OTHER'}, {'name': "Shenzhen Fifth People's Hospital", 'class': 'OTHER'}, {'name': 'Guangzhou Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Min Xia', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}