Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 12:36 AM
Study NCT ID:
NCT03529760
Status:
UNKNOWN
Last Update Posted:
2019-07-16
First Post:
2018-05-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chemotherapy Efficacy and Follow-up Study of Hepatitis B Virus Infection and Reactivation in Children With Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Separating serum, stored at -80 degrees Celsius'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2020-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-13', 'studyFirstSubmitDate': '2018-05-08', 'studyFirstSubmitQcDate': '2018-05-08', 'lastUpdatePostDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HBV-DNA positive', 'timeFrame': '1-year', 'description': 'Positive HBV nucleic acid test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Leukemia, occult hepatitis B virus infection'], 'conditions': ['Reactivation of Hepatitis B Virus']}, 'descriptionModule': {'briefSummary': 'Children with clinically diagnosed leukemia may experience occult HBV infection after chemotherapy immunosuppressive therapy, which may affect the normal course of leukemia treatment. However, this is not caused by clinically relevant diagnosis and treatment measures but exists in vivo.', 'detailedDescription': 'The clinical diagnosis of children with leukemia may be due to the influence of leukemia disease on the immune cells of the children and the damage to the immune system due to immunosuppressive therapy in children. Therefore, the risk of contracting hepatitis B virus is relatively high, and some children are In the treatment of immunosuppressive chemotherapy (later), the reactivation of occult HBV infection has an impact on the normal course of leukemia treatment. However, this is not a clinically relevant diagnosis and treatment measure. It is necessary to avoid unnecessary conflicts between clinical doctors and patients as much as possible.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1-16-year-old leukemia hospitalized chemotherapy children', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe clinical diagnosis of children with leukemia received systemic chemotherapy.\n\nExclusion Criteria:\n\nChildren with non-leukemia and children without appropriate treatment.'}, 'identificationModule': {'nctId': 'NCT03529760', 'briefTitle': 'Chemotherapy Efficacy and Follow-up Study of Hepatitis B Virus Infection and Reactivation in Children With Leukemia', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Chongqing Medical University"}, 'officialTitle': 'Chemotherapy Efficacy and Follow-up Study of Hepatitis B Virus Infection and Reactivation in Children With Leukemia', 'orgStudyIdInfo': {'id': '2018-27'}}, 'contactsLocationsModule': {'locations': [{'zip': '400014', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yao Zhao', 'role': 'CONTACT'}], 'facility': "Chongqing Children's Hospital of Chongqing Medical University", 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Yao Zhao', 'role': 'CONTACT', 'email': 'Zhaoy@cqmu.edu.cn', 'phone': '86-23-6360-3083'}], 'overallOfficials': [{'name': 'Yao Zhao', 'role': 'STUDY_DIRECTOR', 'affiliation': "Chongqing Children's Hospital of Chongqing Medical University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Chongqing Medical University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Qiu Li', 'investigatorAffiliation': "Children's Hospital of Chongqing Medical University"}}}}