Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-01-02 @ 5:15 AM
Study NCT ID:
NCT01076569
Status:
COMPLETED
Last Update Posted:
2016-05-19
First Post:
2010-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers in Bone Marrow Samples From Pediatric Patients With High-Risk Acute Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015472', 'term': 'Leukemia, Eosinophilic, Acute'}], 'ancestors': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'bone marrow'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-17', 'studyFirstSubmitDate': '2010-02-25', 'studyFirstSubmitQcDate': '2010-02-25', 'lastUpdatePostDateStruct': {'date': '2016-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detailed molecular map of pediatric high-risk acute myeloid leukemia', 'timeFrame': 'Baseline'}, {'measure': 'Mutations in identifying novel changes associated with pediatric AML', 'timeFrame': 'Baseline'}, {'measure': 'Expression profile in identifying novel changes associated with pediatric AML', 'timeFrame': 'Baseline'}, {'measure': 'Gene copy number in identifying novel changes associated with pediatric AML', 'timeFrame': 'Baseline'}, {'measure': 'LOH status in identifying novel changes associated with pediatric AML', 'timeFrame': 'Baseline'}, {'measure': 'Genomic methylation patterns in identifying novel changes associated with pediatric AML', 'timeFrame': 'Baseline'}, {'measure': 'Genomic and transcriptome alterations associated with induction failure', 'timeFrame': 'Baseline'}, {'measure': 'Genomic alterations contributing to induction failure in childhood AML', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Childhood Acute Basophilic Leukemia', 'Childhood Acute Eosinophilic Leukemia', 'Childhood Acute Erythroleukemia (M6)', 'Childhood Acute Megakaryocytic Leukemia (M7)', 'Childhood Acute Minimally Differentiated Myeloid Leukemia (M0)', 'Childhood Acute Monoblastic Leukemia (M5a)', 'Childhood Acute Monocytic Leukemia (M5b)', 'Childhood Acute Myeloblastic Leukemia With Maturation (M2)', 'Childhood Acute Myeloblastic Leukemia Without Maturation (M1)', 'Childhood Acute Myelomonocytic Leukemia (M4)', 'Recurrent Childhood Acute Myeloid Leukemia', 'Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies']}, 'descriptionModule': {'briefSummary': 'This pilot research trial studies biomarkers in bone marrow samples from pediatric patients with high risk acute myeloid leukemia. Studying samples of bone marrow from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To provide a detailed, molecular map of pediatric high risk acute myeloid leukemia (AML).\n\nII. To identify mutations, expression profile, gene copy number, loss of heterozygosity (LOH) status and genomic methylation patterns in order to identify novel changes associated with pediatric AML.\n\nIII. To generate fibroblast cell lines in order to obtain germline nucleic acids from marrow specimens from AML patients with induction failure.\n\nIV. To identify genomic alterations contributing to induction failure in childhood AML.\n\nOUTLINE:\n\nBanked bone marrow samples from diagnosis and remission are used to develop a detailed molecular map of pediatric high-risk acute myeloid leukemia. Analysis includes genome single nucleotide polymorphism (SNP) genotyping, expression, and methylation profiling.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any patient with a diagnosis of acute myeloid leukemia meeting the other criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of acute myeloid leukemia\n\n * High-risk disease\n* Treated on COG-AAML03P1 or COG-AAML0531\n* Meets the following criteria:\n\n * Initial remission with no known adverse risk factors\n * High quantity and quality of ribonucleic acid (RNA) and deoxyribonucleic acid (DNA) available\n * Highly enriched specimens with \\>= 50% blast available'}, 'identificationModule': {'nctId': 'NCT01076569', 'briefTitle': 'Biomarkers in Bone Marrow Samples From Pediatric Patients With High-Risk Acute Myeloid Leukemia', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'Target: Identification for High Risk Childhood AML Based on Genome-Wide Analysis', 'orgStudyIdInfo': {'id': 'AAML10B14'}, 'secondaryIdInfos': [{'id': 'NCI-2011-02212', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'COG-AAML10B14', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'AAML10B14', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'AAML10B14', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA098543', 'link': 'https://reporter.nih.gov/quickSearch/U10CA098543', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ancillary-Correlative (molecular analysis)', 'description': 'Banked bone marrow samples from diagnosis and remission are used to develop a detailed molecular map of pediatric high-risk acute myeloid leukemia. Analysis includes genome SNP genotyping, expression, and methylation profiling.', 'interventionNames': ['Other: laboratory biomarker analysis']}], 'interventions': [{'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Ancillary-Correlative (molecular analysis)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91006-3776', 'city': 'Monrovia', 'state': 'California', 'country': 'United States', 'facility': "Children's Oncology Group", 'geoPoint': {'lat': 34.14806, 'lon': -117.99895}}], 'overallOfficials': [{'name': 'Soheil Meshinchi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Oncology Group"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Oncology Group", 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}