Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-01-29 @ 7:19 AM
Study NCT ID:
NCT00898092
Status:
UNKNOWN
Last Update Posted:
2021-08-17
First Post:
2009-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetics Study of Tissue Collected From Patients With Acute Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D015479', 'term': 'Leukemia, Myelomonocytic, Acute'}, {'id': 'D007948', 'term': 'Leukemia, Monocytic, Acute'}, {'id': 'D004915', 'term': 'Leukemia, Erythroblastic, Acute'}, {'id': 'D007947', 'term': 'Leukemia, Megakaryoblastic, Acute'}, {'id': 'D015472', 'term': 'Leukemia, Eosinophilic, Acute'}, {'id': 'D015471', 'term': 'Leukemia, Basophilic, Acute'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D046228', 'term': 'Microarray Analysis'}, {'id': 'D005820', 'term': 'Genetic Testing'}, {'id': 'D016133', 'term': 'Polymerase Chain Reaction'}, {'id': 'D020133', 'term': 'Reverse Transcriptase Polymerase Chain Reaction'}], 'ancestors': [{'id': 'D046208', 'term': 'Microchip Analytical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D033142', 'term': 'Genetic Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D021141', 'term': 'Nucleic Acid Amplification Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 735}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'lastUpdateSubmitDate': '2021-08-16', 'studyFirstSubmitDate': '2009-05-09', 'studyFirstSubmitQcDate': '2009-05-09', 'lastUpdatePostDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prognostic stratification of patients through BAALC and ERG overexpression and microarray gene-expression signatures', 'timeFrame': 'Baseline'}, {'measure': 'Differential microRNA expression', 'timeFrame': 'Baseline'}, {'measure': 'Relative contribution of genetic markers in predicting clinical outcome', 'timeFrame': 'Baseline'}]}, 'conditionsModule': {'keywords': ['adult acute minimally differentiated myeloid leukemia (M0)', 'adult acute myeloblastic leukemia without maturation (M1)', 'adult acute myeloblastic leukemia with maturation (M2)', 'adult acute myelomonocytic leukemia (M4)', 'adult acute monoblastic leukemia (M5a)', 'adult acute monocytic leukemia (M5b)', 'adult erythroleukemia (M6a)', 'adult pure erythroid leukemia (M6b)', 'adult acute megakaryoblastic leukemia (M7)', 'adult acute eosinophilic leukemia', 'adult acute basophilic leukemia', 'untreated adult acute myeloid leukemia'], 'conditions': ['Leukemia']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Collecting and storing samples of tissue and blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.\n\nPURPOSE: This laboratory study is looking at changes in the DNA of tissue samples that were collected from patients with acute myeloid leukemia.', 'detailedDescription': 'OBJECTIVES:\n\n* Validate, on the larger number of patients with karyotypically normal acute myeloid leukemia (AML) treated uniformly on CALGB-19808, preliminary results from CALGB-9621 showing that BAALC and ERG overexpression and microarray gene-expression signatures can stratify the patients prognostically.\n* Establish whether microRNAs are differentially expressed in subsets of patients with AML and normal cytogenetics, and, if so, attempt to identify a signature that stratifies patients prognostically.\n* Explore the relative contribution in predicting clinical outcome of patients with cytogenetically normal AML using genetic markers such as BAALC, ERG, and EVI1 overexpression, MLL partial tandem duplication, FLT3 internal tandem duplication, NPM1 and CEBPA mutations, and microarray gene expression microRNA signatures.\n\nOUTLINE: This is a multicenter, pilot study.\n\nPeripheral blood and bone marrow samples are analyzed to assess gene expression using polymerase chain reaction (PCR) or reverse transcriptase-PCR assays and microarray assays. Genes to be studied include BAALC, ERB, EVI1, MLL, FLT3, NPM1, and CEBPA.\n\nPROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '59 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients enrolled on CALGB 19808 with tissue previously submitted to the CALGB Leukemia Tissue Bank', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of acute myeloid leukemia\n\n * Normal karyotype\n* Bone marrow and/or peripheral blood samples from patients treated on CALGB-19808 and registered on CALGB-9665 required\n\n * No additional samples required'}, 'identificationModule': {'nctId': 'NCT00898092', 'briefTitle': 'Genetics Study of Tissue Collected From Patients With Acute Myeloid Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Alliance for Clinical Trials in Oncology'}, 'officialTitle': 'Molecular Genetic Studies of Acute Myeloid Leukemia (AML) With Normal Cytogenetics. A CALGB Leukemia Tissue Bank Project', 'orgStudyIdInfo': {'id': 'CALGB-20502'}, 'secondaryIdInfos': [{'id': 'CALGB-20502'}, {'id': 'U10CA031946', 'link': 'https://reporter.nih.gov/quickSearch/U10CA031946', 'type': 'NIH'}, {'id': 'U10CA180821', 'link': 'https://reporter.nih.gov/quickSearch/U10CA180821', 'type': 'NIH'}, {'id': 'CDR0000491133', 'type': 'REGISTRY', 'domain': 'NCI Physician Data Query'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Peripheral blood and bone marrow samples are analyzed to assess gene expression using polymerase chain reaction (PCR) or reverse transcriptase-PCR assays and microarray assays. Genes to be studied include BAALC, ERB, EVI1, MLL, FLT3, NPM1, and CEBPA.', 'interventionNames': ['Genetic: microarray analysis', 'Genetic: molecular genetic technique', 'Genetic: mutation analysis', 'Genetic: polymerase chain reaction', 'Genetic: reverse transcriptase-polymerase chain reaction', 'Other: diagnostic laboratory biomarker analysis']}], 'interventions': [{'name': 'microarray analysis', 'type': 'GENETIC', 'armGroupLabels': ['Group 1']}, {'name': 'molecular genetic technique', 'type': 'GENETIC', 'armGroupLabels': ['Group 1']}, {'name': 'mutation analysis', 'type': 'GENETIC', 'armGroupLabels': ['Group 1']}, {'name': 'polymerase chain reaction', 'type': 'GENETIC', 'armGroupLabels': ['Group 1']}, {'name': 'reverse transcriptase-polymerase chain reaction', 'type': 'GENETIC', 'armGroupLabels': ['Group 1']}, {'name': 'diagnostic laboratory biomarker analysis', 'type': 'OTHER', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210-1240', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Guido Marcucci, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ohio State University Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alliance for Clinical Trials in Oncology', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}