Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-02-22 @ 4:52 PM
Study NCT ID:
NCT01229956
Status:
COMPLETED
Last Update Posted:
2016-05-19
First Post:
2010-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers in Tissue Samples From Young Patients With Acute Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}], 'ancestors': [{'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': 'D019175', 'term': 'DNA Methylation'}, {'id': 'D020869', 'term': 'Gene Expression Profiling'}, {'id': 'D046228', 'term': 'Microarray Analysis'}, {'id': 'D020133', 'term': 'Reverse Transcriptase Polymerase Chain Reaction'}], 'ancestors': [{'id': 'D008745', 'term': 'Methylation'}, {'id': 'D000478', 'term': 'Alkylation'}, {'id': 'D001669', 'term': 'Biochemical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}, {'id': 'D008660', 'term': 'Metabolism'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D046208', 'term': 'Microchip Analytical Procedures'}, {'id': 'D016133', 'term': 'Polymerase Chain Reaction'}, {'id': 'D021141', 'term': 'Nucleic Acid Amplification Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'lastUpdateSubmitDate': '2016-05-17', 'studyFirstSubmitDate': '2010-10-27', 'studyFirstSubmitQcDate': '2010-10-27', 'lastUpdatePostDateStruct': {'date': '2016-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of differential patterns of promoter hypermethylation and gene expression in pairwise comparisons with other cohorts and normal controls'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['childhood acute myeloid leukemia in remission', 'recurrent childhood acute myeloid leukemia', 'untreated childhood acute myeloid leukemia and other myeloid malignancies'], 'conditions': ['Leukemia']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying samples of tissue from patients with cancer the in laboratory may help doctors identify and learn more about biomarkers related to cancer.\n\nPURPOSE: This research study is studying biomarkers in tissue samples from young patients with acute myeloid leukemia.', 'detailedDescription': 'OBJECTIVES:\n\n* To determine whether the pattern of global and TSG-specific promoter CpG island hypermethylation and gene silencing that we have shown characterizes MLL-rearranged (MLL-r) infant bilineage ALL is also characteristic of other subsets of MLL-r leukemia.\n\nOUTLINE: Previously collected cryopreserved cells from diagnosis are analyzed for promoter methylation via HELP arrays, gene expression arrays, and RT-qPCR.\n\nPROJECTED ACCRUAL: A total of 32 samples (8 from each of 4 biologically defined cohorts) will be analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients With Acute Myeloid Leukemia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Available cryopreserved cells from diagnosis\n\n * At least 2 x 10\\^7 viably cryopreserved cells\n* One of the following biologically defined cytogenetics/molecular cohorts:\n\n * t(9;11)\n * t(11;19)\n * Other 11q23 translocations\n * Normal cytogenetics\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT01229956', 'briefTitle': 'Biomarkers in Tissue Samples From Young Patients With Acute Myeloid Leukemia', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'Promoter Methylation in MLL-Rearranged Childhood AML', 'orgStudyIdInfo': {'id': 'AAML11B3'}, 'secondaryIdInfos': [{'id': 'COG-AAML11B3', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'NCI-2011-02842', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'AAML11B3', 'type': 'OTHER', 'domain': "Children's Oncology Group"}]}, 'armsInterventionsModule': {'interventions': [{'name': 'DNA methylation analysis', 'type': 'GENETIC'}, {'name': 'gene expression analysis', 'type': 'GENETIC'}, {'name': 'microarray analysis', 'type': 'GENETIC'}, {'name': 'reverse transcriptase-polymerase chain reaction', 'type': 'GENETIC'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Patrick N. Brown, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRISTUS Santa Rosa Cancer Center at CHRISTUS Santa Rosa Hospital - City Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Oncology Group", 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}