Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:10 PM
Study NCT ID:
NCT04012658
Status:
RECRUITING
Last Update Posted:
2019-09-23
First Post:
2019-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Registered Cohort Study on Wilson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006527', 'term': 'Hepatolenticular Degeneration'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020739', 'term': 'Brain Diseases, Metabolic, Inborn'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D008664', 'term': 'Metal Metabolism, Inborn Errors'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2049-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-19', 'studyFirstSubmitDate': '2019-07-06', 'studyFirstSubmitQcDate': '2019-07-06', 'lastUpdatePostDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2039-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The change of Unified Wilson's Disease Rating Scale (UWDRS)", 'timeFrame': 'Up to 30years', 'description': "Disease severity will be assessed by application of the Unified Wilson's Disease Rating Scale (UWDRS), a clinical rating scale consists of three subscales. Higher UWDRS total scores indicate more severe disease."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Wilson's Disease", 'Nature history', 'Genetics'], 'conditions': ["Wilson's Disease"]}, 'descriptionModule': {'briefSummary': "The aim of this study is to determine the clinical spectrum and natural progression of Wilson's Disease in a prospective multicenter natural history study, to assess the clinical, genetic, epigenetic features and biomarkers of patients with Wilson's Disease to optimize clinical management."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients with Wilson's Disease are diagnosed by the clinical and/or genetic features", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with the genetic diagnosis of Wilson's Disease\n* Asymptomatic Wilson's Disease carriers\n* Relatives of Wilson's Disease patients or carriers\n* Unrelated healthy controls\n* Participants or Parent(s)/legal guardian(s) willing and able to complete the informed consent process\n\nExclusion Criteria:\n\n\\* Participants are unable to comply with study procedures and visit schedule"}, 'identificationModule': {'nctId': 'NCT04012658', 'briefTitle': "A Registered Cohort Study on Wilson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Fujian Medical University'}, 'officialTitle': "A Registered Cohort Study on Wilson's Disease", 'orgStudyIdInfo': {'id': 'MRCTA,ECFAH OF FMU[2019]197'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Patients with the genetic diagnosis of Wilson's Disease", 'interventionNames': ['Other: No intervention']}, {'label': "Asymptomatic Wilson's Disease carriers", 'interventionNames': ['Other: No intervention']}, {'label': "Relatives of Wilson's Disease patients or carriers", 'interventionNames': ['Other: No intervention']}, {'label': 'Unrelated healthy controls', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ["Asymptomatic Wilson's Disease carriers", "Patients with the genetic diagnosis of Wilson's Disease", "Relatives of Wilson's Disease patients or carriers", 'Unrelated healthy controls']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fuzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jin He, MD', 'role': 'CONTACT', 'phoneExt': '+1386061359'}, {'role': 'CONTACT', 'email': 'hejinfjmu@hotmail.com', 'phone': '86-0591-87982772'}, {'name': 'Wan-Jin Chen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ning Wanf, MD,PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'First Affiliated Hospital of Fujian Medical University', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}], 'centralContacts': [{'name': 'Jin He, MD', 'role': 'CONTACT', 'email': 'hejinfjmu@hotmail.com', 'phone': '86-0591-87982772'}, {'name': 'Yi Lin, MD.PhD', 'role': 'CONTACT', 'email': 'linyi7811@163.com', 'phone': '8613615039153'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wan-Jin Chen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'The Vice-Director for the Department of Neurology', 'investigatorFullName': 'Wan-Jin Chen', 'investigatorAffiliation': 'First Affiliated Hospital of Fujian Medical University'}}}}