Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-03-05 @ 1:04 AM
Study NCT ID:
NCT01024127
Status:
COMPLETED
Last Update Posted:
2016-05-18
First Post:
2009-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Studying DNA in Blood and Bone Marrow Samples From Younger Patients With Acute Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood and bone marrow'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'lastUpdateSubmitDate': '2016-05-17', 'studyFirstSubmitDate': '2009-12-01', 'studyFirstSubmitQcDate': '2009-12-01', 'lastUpdatePostDateStruct': {'date': '2016-05-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of first acute myeloid leukemia relapse', 'timeFrame': 'Up to 2 years'}, {'measure': 'Rate of invasive bacterial infections defined as the number of invasive infection episodes divided by the days at risk', 'timeFrame': 'From study entry date to completion of therapy date provided on the final Reporting Period case reporting form, assessed up to 2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Adult Acute Myeloid Leukemia in Remission', 'Childhood Acute Myeloid Leukemia in Remission']}, 'descriptionModule': {'briefSummary': 'This research trial studies deoxyribonucleic acid (DNA) in blood or bone marrow samples from younger patients with acute myeloid leukemia. Studying samples of blood and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how well patients will respond to treatment.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nl. Perform a genome-wide scan to test for loci associated with acute myeloid leukemia (AML) relapse and infection risk.\n\nII. Validate positive associations seen in the genome-wide scan with a fine mapping approach.\n\nIII. Perform simulated clinical trials using germline genetic variation data to test the feasibility of using genetic data to inform the clinical care of pediatric patients with AML.\n\nOUTLINE:\n\nGermline DNA is obtained from previously collected peripheral blood or bone marrow samples for array-based genotyping studies, including genome-wide association studies (single nucleotide polymorphisms) and fine mapping genotyping. Clinical trial simulations are performed to test the clinical applicability of using genetic variation data in the management of infectious complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Diagnosis of AML in remission', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of AML\n\n * In remission\n* Adequate DNA from peripheral blood or bone marrow samples\n* Concurrent enrollment on CCG-2961, COG-AAML03P1, COG-AAML0531, AML-93, AML-97, AML-04,AML-09, or Canada AML Infection clinical trial required'}, 'identificationModule': {'nctId': 'NCT01024127', 'briefTitle': 'Studying DNA in Blood and Bone Marrow Samples From Younger Patients With Acute Myeloid Leukemia', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'Genetic Predictors of AML Treatment Response', 'orgStudyIdInfo': {'id': 'AAML10B11'}, 'secondaryIdInfos': [{'id': 'NCI-2011-02202', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'CDR0000660540', 'type': 'OTHER', 'domain': 'Clinical Trials.gov'}, {'id': 'COG-AAML10B11', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'AAML10B11', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'AAML10B11', 'type': 'OTHER', 'domain': 'CTEP'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ancillary-correlative (predictors of AML treatment outcomes)', 'description': 'Germline DNA is obtained from previously collected peripheral blood or bone marrow samples for array-based genotyping studies, including genome-wide association studies (single nucleotide polymorphisms) and fine mapping genotyping. Clinical trial simulations are performed to test the clinical applicability of using genetic variation data in the management of infectious complications.', 'interventionNames': ['Other: Laboratory Biomarker Analysis']}], 'interventions': [{'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Ancillary-correlative (predictors of AML treatment outcomes)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Oncology Group", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Richard Aplenc, 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'}}}}