Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2026-03-03 @ 12:26 PM
Study NCT ID:
NCT02927106
Status:
COMPLETED
Last Update Posted:
2020-08-05
First Post:
2016-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Beat AML Core Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D007938', 'term': 'Leukemia'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Perform molecular and cellular studies on blood, skin biopsy, and bone marrow samples done at the time of diagnosis, after treatments, disease progression, and relapse.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-03', 'studyFirstSubmitDate': '2016-10-05', 'studyFirstSubmitQcDate': '2016-10-05', 'lastUpdatePostDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the genomic abnormality spectrum', 'timeFrame': '5 years', 'description': 'AML cells in the peripheral blood and bone marrow samples will be examined by next generation sequencing using an Illumina DNA sequencer. DNA from the skin biopsy will be used as the constitutional reference DNA. Using skin DNA greatly improves the ability to accurately and precisely identify somatic mutations in the AML cells.'}, {'measure': 'drug sensitivity', 'timeFrame': '5 years', 'description': "Ex vivo drug sensitivity testing will be performed on each subject's AML cells derived from peripheral blood and bone marrow. AML cell viability will be recorded for each treatment condition after 72 hours of treatment. A rank-ordered list of drugs will be created in order of drug toxicity."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['leukemia', 'myeloid', 'genomics'], 'conditions': ['Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'In this study, DNA sequencing, computational biology modeling, and ex vivo drug sensitivity assays will be utilized to define clinically relevant gene mutations and identify potential therapeutics for patients with acute myeloid leukemia (AML).', 'detailedDescription': 'As part of normal clinical care, patients will undergo a peripheral blood draw and bone marrow aspiration \\& biopsy. Blood draws and bone marrow aspirations are performed at the time of diagnosis, after treatments , disease progression, and relapse. Under normal clinical care, patient specimens are analyzed by cytogenetics (giemsa staining), fluorescence in situ hybridization (FISH), and gene mutation profiling. Clinically, treatment can begin before these molecular diagnostics are available.\n\nAs part of this repository study, subjects are asked to:\n\n* Allow access to banked blood and bone marrow specimens in IRB approved protocol # 532-2012.\n* Donate peripheral blood specimens whenever blood is already being drawn for clinical purposes such as at times of diagnosis, relapse, refractory disease or disease progression. Additional samples may be requested at other standard of care visits in the event that initial samples are not viable for DNA sequencing, phenotyping, or functional assays for patients with AML, if disease is present.\n* Donate bone marrow aspirate specimens whenever bone marrow aspiration is already being done for clinical purposes such as at times of diagnosis, relapse, refractory disease or disease progression. If bone marrow aspirate is being collected for banking protocol #532-2012, then an aliquot of the banked specimen will be accessed rather than collect an additional bone marrow aspirate for this study.\n* Undergo skin biopsy and donate the skin biopsy specimen for genomic profiling.\n* Allow bone marrow, peripheral blood and skin biopsy specimens to be collected for genomic profiling and ex vivo drug sensitivity testing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 50 subjects with newly diagnosed or relapsed/refractory acute myeloid leukemia (AML) will be enrolled in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals with newly diagnosed or relapsed/refractory Acute Myeloid Leukemia (AML) as defined by World Health Organization 2016.\n* ≥ 18 years of age\n* Capable of providing informed consent\n\nExclusion Criteria:\n\n* 17 years of age or less\n* greater than 80 years of age'}, 'identificationModule': {'nctId': 'NCT02927106', 'briefTitle': 'Beat AML Core Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Beat AML: Personalized Medicine for Acute Myeloid Leukemia Based on Functional Genomics', 'orgStudyIdInfo': {'id': 'IRB201601364'}, 'secondaryIdInfos': [{'id': 'OCR13966', 'type': 'OTHER', 'domain': 'University of Florida'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acute Myeloid Leukemia (AML)', 'description': 'AML samples will be collected from individuals with newly diagnosed or relapsed/refractory Acute Myeloid Leukemia (AML) as defined by World Health Organization 2016.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'UF Health Cancer Center', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Christopher R. Cogle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oregon Health and Science University', 'class': 'OTHER'}, {'name': 'Cellworks Group Inc.', 'class': 'INDUSTRY'}, {'name': 'The Leukemia and Lymphoma Society', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}