Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-01-24 @ 6:31 PM
Study NCT ID:
NCT05787951
Status:
UNKNOWN
Last Update Posted:
2023-03-28
First Post:
2023-03-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Frequency and Risk Factors of Acute Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-15', 'studyFirstSubmitDate': '2023-03-15', 'studyFirstSubmitQcDate': '2023-03-15', 'lastUpdatePostDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of acute myeloid leukemia at clinical Haemtology unit of Assiute university hospital', 'timeFrame': 'Two years'}], 'secondaryOutcomes': [{'measure': 'Risk factors of acute myeloid leukemia at clinical Haemtology unit of Assiute university hospital', 'timeFrame': 'Two years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myeloid Leukemia']}, 'referencesModule': {'references': [{'pmid': '32719169', 'type': 'BACKGROUND', 'citation': 'Hwang SM. Classification of acute myeloid leukemia. Blood Res. 2020 Jul 31;55(S1):S1-S4. doi: 10.5045/br.2020.S001.'}]}, 'descriptionModule': {'briefSummary': '1. to assess the frequency of acute myeloid leukemia at clinical Haematology unit of Assiute university hospital\n2. to study correlations of known risk factors and if there are new risk factors participate in increasing frequency of acute myeloid leukemia', 'detailedDescription': 'Acute myeloid leukaemia (AML) is a rare heterogeneous disease comprising a group of hematopoietic neoplasms originating from the excessive clonal proliferation of myeloid pre- cursor cells \\[1\\]. Diagnosis of AML is based on morphological diagnosis with proliferation of blast cells ≥ 20% of bone marrow cells, flow cytometric analysis and cytogenetic abnormalities, including the t(8;21)(q22;q22), t(15;17) (q22;q12) and inv (16)(p13.1;q22) which are associated with longer remission and survival, while alterations of chromosomes 5, 7, complex karyotype and 11q23 are associated with poor response to therapy and shorter overall survival \\[2\\] The etiological agent and pathogenesis of AML are not entirely clear, only few AML cases can be accurately classified through traditional cellular morphological classification \\[3\\]It is the most common acute leukaemia in adults. It accounts for 1.3% of new cancer patients in the United States, in 2018\\[ 4\\] Some factors are well documented to increase the risk of some types of leukemia such as benzene exposure and ionizing radiation \\[5\\] increased frequency of acute myeloid leukemia has been noticed at Haematology unit so the aim of the study to assess the the frequency of acute myeloid leukemia and to evaluate the risk factors for it .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult Patients(above 18 years) diagnosed as acute myeloid leukemia according to WHO diagnostic criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult Patients(above 18 years) diagnosed as acute myeloid leukemia according to WHO diagnostic criteria\n\nExclusion Criteria:\n\n* Patients with other types of leukemia'}, 'identificationModule': {'nctId': 'NCT05787951', 'briefTitle': 'Frequency and Risk Factors of Acute Myeloid Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Frequency and Risk Factors of Acute Myeloid Leukemia at Clinical Haemtology Unit of Assiut University Hospital', 'orgStudyIdInfo': {'id': 'Risk factors of AML'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Bone marrow aspirite for diagnosis', 'type': 'DIAGNOSTIC_TEST', 'description': 'Routine investigation of acute myeloid leukemia such as bone marrow aspirite for diagnosis ,cbc'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sanaa Hussien', 'role': 'CONTACT', 'email': 'Sanaaezzate212@gmail.com', 'phone': '00201023127310'}, {'name': 'Osama Ibrahim', 'role': 'CONTACT', 'email': 'Oibrahiem@yahoo.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Sanaa Ezzat Hussien', 'investigatorFullName': 'Sanaa Ezzat Hussien', 'investigatorAffiliation': 'Assiut University'}}}}