Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2026-01-03 @ 10:58 PM
Study NCT ID:
NCT05839392
Status:
RECRUITING
Last Update Posted:
2023-12-29
First Post:
2023-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel Approaches to Target MECOM/EVI1 in AML
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074008', 'term': 'MDS1 and EVI1 Complex Locus Protein'}], 'ancestors': [{'id': 'D004268', 'term': 'DNA-Binding Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011518', 'term': 'Proto-Oncogene Proteins'}, {'id': 'D015513', 'term': 'Oncogene Proteins'}, {'id': 'D009363', 'term': 'Neoplasm Proteins'}, {'id': 'D014157', 'term': 'Transcription Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-22', 'studyFirstSubmitDate': '2023-04-21', 'studyFirstSubmitQcDate': '2023-04-21', 'lastUpdatePostDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of MECOM/EVI1 regulators or downstream effectors potentially druggable', 'timeFrame': 'At baseline', 'description': 'To assess the number of regulators or effectors of MECOM/EVI1'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['AML, Adult']}, 'descriptionModule': {'briefSummary': 'This is an academic, no-profit, multicenter, biological, non-pharmacologic study aimed at characterizing genome, transcriptome and proteome of patients affected by AML with MECOM or atypical 3q26 rearrangements.', 'detailedDescription': 'This is an academic, no-profit, multicenter, biological, non-pharmacologic study aimed at characterizing genome, transcriptome and proteome of patients affected by AML with MECOM or atypical 3q26 rearrangements. To this end, BM samples and formalin fixed/paraffin-embedded BM biopsies will be collected at enrolment, before and after treatment, at relapse.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* AML with MECOM or atypical 3q26 rearrangements.\n* Age ≥18.\n* Signed written informed consent according to ICH/EU/GCP and national local laws.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT05839392', 'briefTitle': 'Novel Approaches to Target MECOM/EVI1 in AML', 'organization': {'class': 'OTHER', 'fullName': "Gruppo Italiano Malattie EMatologiche dell'Adulto"}, 'officialTitle': 'Novel Approaches to Target MECOM/EVI1 in Acute Myeloid Leukemia', 'orgStudyIdInfo': {'id': 'AML2623'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Biological characterization of AML with MECOM or atypical 3q26 rearrangements', 'type': 'BIOLOGICAL', 'description': 'Peripheral blood and bone marrow withdrawal'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Piacenza', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Vallisa', 'role': 'CONTACT'}], 'facility': 'Ematologia', 'geoPoint': {'lat': 45.05242, 'lon': 9.69342}}], 'centralContacts': [{'name': 'Paola Fazi', 'role': 'CONTACT', 'email': 'p.fazi@gimema.it', 'phone': '0670390528'}, {'name': 'Enrico Crea', 'role': 'CONTACT', 'email': 'e.crea@gimema.it', 'phone': '0670390514'}], 'overallOfficials': [{'name': 'Giovanni Roti', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medicine and Surgery, University of Parma, Parma'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Gruppo Italiano Malattie EMatologiche dell'Adulto", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}