Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-03-01 @ 9:59 AM
Study NCT ID:
NCT04084327
Status:
UNKNOWN
Last Update Posted:
2019-09-10
First Post:
2018-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunophenotyping of Acute b Cell Lymphoblstic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-09', 'studyFirstSubmitDate': '2018-10-16', 'studyFirstSubmitQcDate': '2019-09-09', 'lastUpdatePostDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival outcome', 'timeFrame': '10 years', 'description': 'overall survival outcome'}, {'measure': 'Disease-free survival outcome', 'timeFrame': '10 years', 'description': 'Disease-free survival outcome'}, {'measure': 'association of novel CD markers with old markers for assessment of disease outcome', 'timeFrame': '10 years', 'description': 'association of novel CD markers with old markers for assessment of disease outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Leukemia']}, 'referencesModule': {'references': [{'pmid': '29588374', 'type': 'BACKGROUND', 'citation': 'Keegan A, Charest K, Schmidt R, Briggs D, Deangelo DJ, Li B, Morgan EA, Pozdnyakova O. Flow cytometric minimal residual disease assessment of peripheral blood in acute lymphoblastic leukaemia patients has potential for early detection of relapsed extramedullary disease. J Clin Pathol. 2018 Jul;71(7):653-658. doi: 10.1136/jclinpath-2017-204828. Epub 2018 Mar 27.'}]}, 'descriptionModule': {'briefSummary': 'To study the immunophenotyping pattern of acute B lymphoblastic leukemia in south Egypt Cancer Institute iand its correlation with disease outcome', 'detailedDescription': 'study the immunophenotyping pattern of acute B lymphoblastic leukemia in south Egypt Cancer Institute from 2009 -2019 and its correlation with disease outcome'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '12 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "new cases Who didn't receive treatment.Age above 1 years old.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* New cases admitted to SECI Who didn't receive treatment.Age above 1 years old.\n\nExclusion Criteria:\n\n* Cases who received treatment Patients below 1 years old.Patients diagnosed as AML or T-ALL"}, 'identificationModule': {'nctId': 'NCT04084327', 'briefTitle': 'Immunophenotyping of Acute b Cell Lymphoblstic Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'South Egypt Cancer Institute'}, 'officialTitle': 'Immunophenotyping of Acute b Cell Lymphoblastic Leukemia', 'orgStudyIdInfo': {'id': 'acute b All'}}, 'armsInterventionsModule': {'interventions': [{'name': 'stastical analysis', 'type': 'OTHER', 'description': '1-Clinical examination data-Complete Blood Count (CBC).Bone Marrow Aspiration (BMA)-Bone Marrow Biopsy (BMB). (if available)-Immunophenotyping results (IPT).Cytogenetic results'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Egypt Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'ayat ahmed mohamed', 'investigatorAffiliation': 'South Egypt Cancer Institute'}}}}