Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2026-02-25 @ 11:01 PM
Study NCT ID:
NCT02391168
Status:
UNKNOWN
Last Update Posted:
2015-08-05
First Post:
2015-03-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fatty Liver Disease Collaborative Research in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D005235', 'term': 'Fatty Liver, Alcoholic'}, {'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008108', 'term': 'Liver Diseases, Alcoholic'}, {'id': 'D020751', 'term': 'Alcohol-Induced Disorders'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Liver tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-08-03', 'studyFirstSubmitDate': '2015-03-12', 'studyFirstSubmitQcDate': '2015-03-12', 'lastUpdatePostDateStruct': {'date': '2015-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'liver cirrhosis', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'liver cancer', 'timeFrame': '5 years'}, {'measure': 'liver failure', 'timeFrame': '5 years'}, {'measure': 'type 2 diabetes', 'timeFrame': '5 years'}, {'measure': 'cardiovascular and cerebrovascular events', 'timeFrame': '5 years'}, {'measure': 'death', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Fatty Liver', 'Fatty Liver, Alcoholic', 'Non-alcoholic Fatty Liver Disease']}, 'descriptionModule': {'briefSummary': 'A multi-center, prospective cohort study on the natural history of fatty liver disease in China', 'detailedDescription': 'This is a multicenter, prospective and open-enrollment epidemiologic study. All the patients with liver biopsy-proven macrovesicular steatosis (\\>5%) will be enrolled in the baseline cross-sectional analysis. Those who are either diagnosed as NAFLD or ALD, if meeting all the inclusion and exclusion criteria, will be enrolled in the following cohort study, will be followed up after 1 year, 3 years and 5 years with a visit window of +1 month.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'any person with fatty liver disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinically diagnosed fatty liver disease, confirmed by liver biopsy.\n* Specific biopsy requirements: qualified biopsy specimen within 6 months, \\>5% hepatocytes show macrovesicular steatosis under HE staining and X10 microscope.\n* Only patients with NAFLD or ALD are eligible for the 5-year follow-up cohort study.\n* Willing to participate in the long-term follow-up and cooperative.\n* Able to provide informed consent file.\n\nExclusion Criteria:\n\n* Unable to provide informed consent.\n* Patients are eligible for baseline cross-sectional analysis but not eligible for the cohort section, if having any of the following condition:\n\n 1. Any end-stage liver disease.\n 2. Any malignant tumor.\n 3. Any infection of hepatitis virus or HIV.\n 4. Any congenital liver disease such as Wilson disease.\n 5. Any other serious disease of projected survival \\< 5 years.\n 6. Combined NAFLD and ALD.'}, 'identificationModule': {'nctId': 'NCT02391168', 'acronym': 'FLDCR', 'briefTitle': 'Fatty Liver Disease Collaborative Research in China', 'organization': {'class': 'OTHER', 'fullName': 'Fatty Liver and Alcoholic Liver Disease Study Group, China'}, 'officialTitle': 'A Multi-center, Prospective Cohort Study on the Natural History of Fatty Liver Disease in China', 'orgStudyIdInfo': {'id': 'FLD2015'}}, 'contactsLocationsModule': {'locations': [{'city': 'Zhangzhou', 'state': 'Fujian', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ruidan Zheng, MD', 'role': 'CONTACT'}, {'name': 'Ruidan Zheng, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhangzhou Zhengxing Hospital', 'geoPoint': {'lat': 24.51333, 'lon': 117.65556}}, {'city': "Ji'nan", 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wanhua Ren, MD', 'role': 'CONTACT'}, {'name': 'Wanhua Ren, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shandong Provincial Hospital'}, {'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuqiang Mi, MD', 'role': 'CONTACT'}, {'name': 'Yuqiang Mi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Tianjin Second People's Hospital", 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Ürümqi', 'state': 'Xinjiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fangping He, MD', 'role': 'CONTACT'}, {'name': 'Fangping He, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital of Xinjiang Medical University', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Junping Shi, MD', 'role': 'CONTACT'}, {'name': 'Junping Shi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Affiliated Hospital of Hangzhou Normal University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiangao Fan, MD', 'role': 'CONTACT', 'email': 'fattyliver2004@126.com'}], 'facility': 'Shanghai Xinhua Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jiangao Fan, MD', 'role': 'CONTACT', 'email': 'fattyliver2004@126.com'}, {'name': 'Chao Sun, MD', 'role': 'CONTACT', 'email': 'csun7682@163.com'}], 'overallOfficials': [{'name': 'Jiangao Fan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fatty Liver and Alcoholic Liver Disease Study Group, China', 'class': 'OTHER'}, 'collaborators': [{'name': 'Unimed Scientific Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}