Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-03-03 @ 8:12 AM
Study NCT ID:
NCT03283228
Status:
UNKNOWN
Last Update Posted:
2017-09-14
First Post:
2017-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cd11b and Cd56 as Prognostic Markers in Acute Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2019-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-12', 'studyFirstSubmitDate': '2017-08-27', 'studyFirstSubmitQcDate': '2017-09-12', 'lastUpdatePostDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CD11b and CD56 marker', 'timeFrame': '24 month', 'description': 'Detect the expression of marker CD56 and CD11b in newly diagnosed cases of adult AML.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adult Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': '1. Detect the expression of marker CD56 and CD11b in newly diagnosed cases of adult AML.\n2. Study correlation between CD56 and CD11b expression with haematological parameters in cases of adult AML.', 'detailedDescription': '1. CD11b expression level is a prognostic biomarker for AML patient. CD11b positivity could predict a poor prognosis for AML patients.\n2. CD56 antigen expression, an inexpensive, easy to detect and reproduce index, is closely related to the prognosis of AML patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Anew diagnosis cases of adult AML', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAnew diagnosis cases of adult AML\n\nExclusion Criteria:\n\n1. Pediatric AML .\n2. follow up cases of adult AML'}, 'identificationModule': {'nctId': 'NCT03283228', 'briefTitle': 'Cd11b and Cd56 as Prognostic Markers in Acute Myeloid Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Cd11b and Cd56 as Prognostic Markers in Acute Myeloid Leukemia', 'orgStudyIdInfo': {'id': 'Myeloid Leukemia Markers'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CD11b and CD56 markers', 'description': 'Cd11b and Cd56 as Prognostic Markers in Acute Myeloid Leukemia', 'interventionNames': ['Diagnostic Test: Cd11b and Cd56 markers']}, {'label': 'Haematological parameters in cases of adult AML', 'description': 'Study correlation between CD56 and CD11b expression with haematological parameters in cases of adult AML', 'interventionNames': ['Diagnostic Test: Cd11b and Cd56 markers']}], 'interventions': [{'name': 'Cd11b and Cd56 markers', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Cd11b and Cd56 as Prognostic Markers in Acute Myeloid Leukemia'], 'description': 'The expression of CD11b and CD56 in newly diadnosed cases of AML', 'armGroupLabels': ['CD11b and CD56 markers', 'Haematological parameters in cases of adult AML']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Shaaban Helal, PHD', 'role': 'CONTACT', 'email': 'Elhelal2007@gmail.com', 'phone': '01005688567'}, {'name': 'Eman Salah Eldin, lecture', 'role': 'CONTACT', 'email': 'Emansalah.eldin@yahoo.com', 'phone': '01028030966'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Z A Kamel', 'investigatorAffiliation': 'Assiut University'}}}}