Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2025-12-27 @ 3:49 AM
Study NCT ID:
NCT05809050
Status:
UNKNOWN
Last Update Posted:
2023-04-12
First Post:
2023-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of miRNA-155 in Acute Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-30', 'studyFirstSubmitDate': '2023-03-30', 'studyFirstSubmitQcDate': '2023-03-30', 'lastUpdatePostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of miRNA-155', 'timeFrame': 'one year', 'description': 'Detection of miRNA-155 using real time PCR on bone marrow aspirate samples'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Leukemia']}, 'referencesModule': {'references': [{'pmid': '32620999', 'type': 'BACKGROUND', 'citation': 'Kirtonia A, Pandya G, Sethi G, Pandey AK, Das BC, Garg M. A comprehensive review of genetic alterations and molecular targeted therapies for the implementation of personalized medicine in acute myeloid leukemia. J Mol Med (Berl). 2020 Aug;98(8):1069-1091. doi: 10.1007/s00109-020-01944-5. Epub 2020 Jul 3.'}, {'pmid': '33121874', 'type': 'BACKGROUND', 'citation': "Culp-Hill R, D'Alessandro A, Pietras EM. Extinguishing the Embers: Targeting AML Metabolism. Trends Mol Med. 2021 Apr;27(4):332-344. doi: 10.1016/j.molmed.2020.10.001. Epub 2020 Oct 26."}, {'pmid': '35633629', 'type': 'BACKGROUND', 'citation': 'Dachi RA, Mustapha FG, Mahdi M, Abbas H. Acute Leukaemias in Bauchi State, Northeastern Nigeria: Pattern of Presentations and Clinical Entities. West Afr J Med. 2022 May 27;39(5):497-500.'}, {'pmid': '34028982', 'type': 'BACKGROUND', 'citation': 'Lefeivre T, Jones L, Trinquand A, Pinton A, Macintyre E, Laurenti E, Bond J. Immature acute leukaemias: lessons from the haematopoietic roadmap. FEBS J. 2022 Aug;289(15):4355-4370. doi: 10.1111/febs.16030. Epub 2021 Jun 10.'}]}, 'descriptionModule': {'briefSummary': 'The leukaemias are a heterogeneous group of blood cancers, Acute leukaemia (AL) is caused by malignant proliferation of blood cells arrested at an immature stage of development, They are very aggressive diseases that run a rapidly fatal course if not promptly diagnosed and appropriately treated. Misdiagnosis is very common with delay in diagnosis and prompt treatment being the causes of high morbidity and mortality in acute leukaemias.\n\nAlthough with the continuous improvement of clinical and laboratory diagnosis and treatment methods, the prognosis of AML has been significantly improved, but there are still about 70% of patients who cannot survive more than 5 years after diagnosis The activity of miRNAs in tumors is regulated by the same alterations affecting protein-coding genes, such as chromosomal rearrangements, genomic amplifications or deletions or mutations, abnormal transcriptional control, dysregulation of epigenetic changes and defects in the biogenesis machinery A typical chromosomal rearrangement is a chromosomal translocation, especially in hematological malignancies, in which it promotes tumor development and progression by the promoter exchange or by the creation of chimeric genes translated as fusion proteins. In Acute Myeloid Leukemia (AML) patients with myeloid/lymphoid leukemia gene (or mixed-lineage leukemia, MLL) rearrangement, by large-scale genome-wide microarray analysis, it was demonstrated that among 48 selected miRNAs, 47 of them are increased'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Group (I): represents the control group ( ITP cases). Group (II): represents the cases of Acute Leukemia.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* approval to sign an informed written consent, patient with newly diagnosed AL.\n\nExclusion Criteria:\n\n* Refusal to sign an informed written consent, Cases with Chronic leukemias, Lymphoma or Leukemic phase of lymphoma or patients on chemotherapy.'}, 'identificationModule': {'nctId': 'NCT05809050', 'briefTitle': 'Study of miRNA-155 in Acute Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Study of miRNA-155 in Acute Leukemia', 'orgStudyIdInfo': {'id': 'Soh-Med-23-03-01MD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'control group', 'description': 'represents the control group ( ITP cases', 'interventionNames': ['Diagnostic Test: BM aspirate']}, {'label': 'AL group', 'description': 'cases of AcuteLeukemia.', 'interventionNames': ['Diagnostic Test: BM aspirate']}], 'interventions': [{'name': 'BM aspirate', 'type': 'DIAGNOSTIC_TEST', 'description': 'Bone Marrow aspiration \\& Examination', 'armGroupLabels': ['AL group', 'control group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Noura F Abdullah, specialist', 'role': 'CONTACT', 'email': 'noura.rashwan@med.sohag.edu.eg', 'phone': '01005360731'}, {'name': 'Elham o Hamed, professor', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical pathology specialist at sohag university', 'investigatorFullName': 'Noura Farouk Abdallah', 'investigatorAffiliation': 'Sohag University'}}}}