Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
Study NCT ID:
NCT04477967
Status:
RECRUITING
Last Update Posted:
2020-07-20
First Post:
2020-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Design and Implementation of the Pediatric Liver Transplantation Biobank
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2028-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-15', 'studyFirstSubmitDate': '2020-07-08', 'studyFirstSubmitQcDate': '2020-07-15', 'lastUpdatePostDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biological sample bank', 'timeFrame': '2 years', 'description': "A repository of biological samples from patients who will join the project, will be organised at the biobank center of the Children's Hospital of Chongqing Medical University(CHCMU) under the responsibility of the experienced staff at the Department of Hepatic."}, {'measure': 'Integrated health data platform', 'timeFrame': '2 years', 'description': 'Collect patient clinical test information and establish diagnostic database.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Diseases', 'Liver Transplant; Complications', 'Pediatric ALL']}, 'referencesModule': {'references': [{'pmid': '33847526', 'type': 'DERIVED', 'citation': 'Xiang Z, Wang R, Lu Y, Li Y, Wang H, Xiong Q, Dai X, Guo H, Deng Y, Le Y, Zhang M, Zhao Y. Study Protocol: Design and Implementation of the Pediatric Liver Transplantation Biobank. Biopreserv Biobank. 2021 Apr;19(2):111-118. doi: 10.1089/bio.2020.0128. Epub 2021 Apr 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the pediatric liver transplant biobank is to systematically collect clinical specimens from pediatric end-stage liver disease. It is expected to contribute to the research and development of paediatric end-stage liver disease in the future.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Children with end-stage liver disease who undergo liver transplantation in our hospital. Obtain their or their parents' informed consent before the project starts.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Children diagnosed with end-stage liver disease.\n2. Liver transplantation in our hospital.\n3. informed patient consent.\n4. long-term follow-up in our hospital.\n\nExclusion Criteria:\n\nNo fixed contact information, difficult to follow up the patients.'}, 'identificationModule': {'nctId': 'NCT04477967', 'briefTitle': 'Design and Implementation of the Pediatric Liver Transplantation Biobank', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Chongqing Medical University"}, 'officialTitle': "Children's Hospital of Chongqing Medical University", 'orgStudyIdInfo': {'id': '2018（120）'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'There are no interventions because it is a protocol study'}]}, 'contactsLocationsModule': {'locations': [{'zip': '400014', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yao Zhao, postdoctor', 'role': 'CONTACT'}], 'facility': "Children's Hospital of Chongqing Medical University", 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Xiang Zheng', 'role': 'CONTACT', 'email': 'xiangzheng061@163.com', 'phone': '17723191712'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Chongqing Medical University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'dean', 'investigatorFullName': 'Qiu Li', 'investigatorAffiliation': "Children's Hospital of Chongqing Medical University"}}}}