Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT04298502
Status:
UNKNOWN
Last Update Posted:
2020-10-01
First Post:
2020-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Molecular Mechanism of CMV-driven NKG2C+NK Cell Expansion in Human
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'peripheral blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-30', 'studyFirstSubmitDate': '2020-03-04', 'studyFirstSubmitQcDate': '2020-03-04', 'lastUpdatePostDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CMV viremia', 'timeFrame': '2 moths post-transplantation', 'description': 'CMV-DNA\\>1.0x10\\^3 cpies/mL'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Leukemia', 'CMV Viremia', 'Hematopoietic Stem Cell Transplantation']}, 'descriptionModule': {'briefSummary': 'This is an observation study to investigate the molecular mechanism of NKG2C+NK cell expansion after HCMV infection', 'detailedDescription': 'According to the changes of molecular and gene expression in NK cells at different time points after infection, we want to find out the mechanism by which HCMV promotes the expansion of NKG2C + NK cells.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'AML or MDS or CML or ALL undergoing haploidentical stem cells transplantation AND the healthy donors.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. AML or MDS or CML or ALL undergoing haploidentical stem cells transplantation\n2. No severe organ dysfunction or failure\n3. Subjects must be capable of, and willing to provide written informed consent to participate in the study. Subjects unable to provide written informed consent by themselves may be consented through their legal representative.\n\nExclusion Criteria:\n\n1. Participation in another industry-sponsored clinical study where treatment for CMV is already specified by the study protocol.\n2. Patients received other adoptive immunotherapy such as donor lymphocyte infusion (DLI), Epstein-Barr virus (EBV)-specific T cells and so on.'}, 'identificationModule': {'nctId': 'NCT04298502', 'briefTitle': 'The Molecular Mechanism of CMV-driven NKG2C+NK Cell Expansion in Human', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'The Molecular Mechanism of CMV-driven NKG2C+NK Cell Expansion in Human', 'orgStudyIdInfo': {'id': 'HCMV-NKG2C+ NK cell'}}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiangyu Zhao', 'role': 'CONTACT'}], 'facility': 'Peking University Institute of Hematology', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xiangyu Zhao, M.D., PhD', 'role': 'CONTACT', 'email': 'xyz80421@126.com', 'phone': '+8610-88325949'}], 'overallOfficials': [{'name': 'Xiaojun Huang, M.D., PhD', 'role': 'STUDY_CHAIR', 'affiliation': "Peking University People's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Peking University Institute of Hematology', 'investigatorFullName': 'Xiaojun Huang,MD', 'investigatorAffiliation': "Peking University People's Hospital"}}}}