Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-01-01 @ 10:30 AM
Study NCT ID:
NCT05477667
Status:
UNKNOWN
Last Update Posted:
2022-07-28
First Post:
2022-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Let-7a and miRNA-124 in Cases of Non-Hodgkin's Lymphoma and Acute Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-26', 'studyFirstSubmitDate': '2022-07-26', 'studyFirstSubmitQcDate': '2022-07-26', 'lastUpdatePostDateStruct': {'date': '2022-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MiRNA-124 level', 'timeFrame': '6 months', 'description': "Detection of expressin level of MiRNA-124 IN Non-Hodgkin's Lymphoma and acute leukemia"}, {'measure': 'let-7a level', 'timeFrame': '6 months', 'description': "Detection of expressin level of let-7a IN Non-Hodgkin's Lymphoma and acute leukemia"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non Hodgkin Lymphoma and Acute Leukemia']}, 'referencesModule': {'references': [{'pmid': '28153383', 'type': 'BACKGROUND', 'citation': 'Armitage JO, Gascoyne RD, Lunning MA, Cavalli F. Non-Hodgkin lymphoma. Lancet. 2017 Jul 15;390(10091):298-310. doi: 10.1016/S0140-6736(16)32407-2. Epub 2017 Jan 31.'}, {'pmid': '28148469', 'type': 'BACKGROUND', 'citation': 'Bedewy AML, Elmaghraby SM, Shehata AA, Kandil NS. Prognostic Value of miRNA-155 Expression in B-Cell Non-Hodgkin Lymphoma. Turk J Haematol. 2017 Aug 2;34(3):207-212. doi: 10.4274/tjh.2016.0286. Epub 2017 Feb 1.'}, {'pmid': '30207593', 'type': 'BACKGROUND', 'citation': 'Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.'}, {'pmid': '32888820', 'type': 'BACKGROUND', 'citation': 'Fuertes T, Ramiro AR, de Yebenes VG. miRNA-Based Therapies in B Cell Non-Hodgkin Lymphoma. Trends Immunol. 2020 Oct;41(10):932-947. doi: 10.1016/j.it.2020.08.006. Epub 2020 Sep 1.'}]}, 'descriptionModule': {'briefSummary': "MiRNAs are noncoding RNAs (ncRNAs) that drive post-transcriptional negative regulation of gene expression by promoting the degradation or translational blockade of their target mRNAs. MiRNAs are 21-24-nucleotide-long RNA molecules that are processed from longer RNA precursors (pri-miRNAs) , and either the 5' or the 3' strand of the mature miRNA duplex is loaded into the Argonaute (AGO) family of proteins to form a miRNA-induced silencing complex (miRISC) When bound to AGO proteins, mature miRNAs destabilize or inhibit the translation of partially complementary target mRNAsMiRNA-124 has been shown to be a tumor suppressor, and a decrease in its expression level is typical of tumors of various localization, but there is no evidence of the role of miRNA-124 in the development of NHL . There are a number of studies reflecting the involvement of miRNA-124 in hematopoiesis. Liu et al. showed that miRNA-124 regulates Tip110 that is involved in the differentiation of hematopoietic stem cellsThe let-7 family has been shown to influence the pathogenesis of a variety of hematological malignancies through the changing expression of a number of oncogenic pathways, particularly those related with MYC and that might affect hematopoietic carcinogenesis through the modulation of inflammatory pathways"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* approval to sign an informed written consent,\n* patient with NHL and acute leukemia .\n\nExclusion Criteria:\n\n* Refusal to sign an informed written consent,\n* patient on chemotherapy'}, 'identificationModule': {'nctId': 'NCT05477667', 'briefTitle': "Study of Let-7a and miRNA-124 in Cases of Non-Hodgkin's Lymphoma and Acute Leukemia", 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': "Study of Let-7a and miRNA-124 in Cases of Non-Hodgkin's Lymphoma and Acute Leukemia", 'orgStudyIdInfo': {'id': 'Soh-Med-22-7-22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'the patients with non-malignant hematological diseases', 'interventionNames': ['Diagnostic Test: real time pcr']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'the cases (A)', 'description': 'NHL .', 'interventionNames': ['Diagnostic Test: real time pcr']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'the cases (B)', 'description': 'acute leukemia', 'interventionNames': ['Diagnostic Test: real time pcr']}], 'interventions': [{'name': 'real time pcr', 'type': 'DIAGNOSTIC_TEST', 'description': 'Detection of expressin level of MiRNA-124 and let-7a using real time pcr', 'armGroupLabels': ['control group', 'the cases (A)', 'the cases (B)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'contacts': [{'name': 'Osama R Elshrif, professor', 'role': 'CONTACT'}], 'facility': 'Sohag University Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'sara t mahmoud, assisstent professor', 'role': 'CONTACT', 'email': 'sara.ahmed@med.sohag.edu.eg', 'phone': '01024914157'}, {'name': 'rania M bakry, professor', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assisstent professor at clinical pathology department at faculty of medicine sohag university hospital', 'investigatorFullName': 'Sara Talal Mahmoud', 'investigatorAffiliation': 'Sohag University'}}}}