Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-25 @ 4:57 PM
Study NCT ID:
NCT05808803
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2023-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Aberrant Myeloid Lineage Differentiation in HIV/AIDS Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D007938', 'term': 'Leukemia'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 782}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-26', 'studyFirstSubmitDate': '2023-02-10', 'studyFirstSubmitQcDate': '2023-04-10', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of granulocytes and granulocyte/macrophage progenitors in myelogram of HIV/AIDS patients', 'timeFrame': '2020', 'description': 'Flow cytometric immunophenotyping of an EDTA-anticoagulated BM aspirate specimen was performed. A standard BM assay with erythrocyte cell lysis was used for all BM aspirate specimens. Flow cytometric analysis was conducted using a FACS Canto II flow cytometer (Becton Dickinson, Sunnyvale, CA, USA).'}], 'secondaryOutcomes': [{'measure': 'Neutrophil counts in peripheral blood of HIV/AIDS patients', 'timeFrame': '2020', 'description': 'Blood samples were drawn from patients undergoing routine diagnostic blood analysis at our institute by sterile venipuncture into tubes containing 5.4 mg of K2EDTA and analyzed by the automated hematology analyzer.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV Infections', 'Leukemia']}, 'descriptionModule': {'briefSummary': 'The investigators included 782 HIV-infected patients from January 2016 to October 2020 Zhongnan Hospital of Wuhan University, whose AIDS diagnosis criteria met the "AIDS Diagnosis and Treatment Guide (2018 edition)" of Chinese Medical Association.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The investigators included 782 HIV-infected patients from January 2016 to October 2020 Zhongnan Hospital of Wuhan University, whose AIDS diagnosis criteria met the "AIDS Diagnosis and Treatment Guide (2018 edition)" of Chinese Medical Association. There were 647 male patients and 135 female patients, aged 14-78 years, with an average age of 43 years.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-infection\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05808803', 'briefTitle': 'Aberrant Myeloid Lineage Differentiation in HIV/AIDS Patients', 'organization': {'class': 'OTHER', 'fullName': 'Zhongnan Hospital'}, 'officialTitle': 'A Single-center, Retrospective Cohort Study of Aberrant Myeloid Lineage Differentiation in HIV/AIDS Patients', 'orgStudyIdInfo': {'id': '05'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HIV without leukemia'}, {'label': 'HIV leukemia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhongnan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}