Biomarkers in Bone Marrow Samples From Pediatric Patients With High-Risk Acute Myeloid Leukemia
NCT ID: NCT01076569
Last Updated: 2016-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
250 participants
OBSERVATIONAL
2010-03-31
2016-05-31
Brief Summary
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Detailed Description
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I. To provide a detailed, molecular map of pediatric high risk acute myeloid leukemia (AML).
II. 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.
III. To generate fibroblast cell lines in order to obtain germline nucleic acids from marrow specimens from AML patients with induction failure.
IV. To identify genomic alterations contributing to induction failure in childhood AML.
OUTLINE:
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 single nucleotide polymorphism (SNP) genotyping, expression, and methylation profiling.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Ancillary-Correlative (molecular analysis)
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.
laboratory biomarker analysis
Correlative studies
Interventions
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laboratory biomarker analysis
Correlative studies
Eligibility Criteria
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Inclusion Criteria
* High-risk disease
* Treated on COG-AAML03P1 or COG-AAML0531
* Meets the following criteria:
* Initial remission with no known adverse risk factors
* High quantity and quality of ribonucleic acid (RNA) and deoxyribonucleic acid (DNA) available
* Highly enriched specimens with \>= 50% blast available
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Soheil Meshinchi, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Oncology Group
Locations
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Children's Oncology Group
Monrovia, California, United States
Countries
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Other Identifiers
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NCI-2011-02212
Identifier Type: REGISTRY
Identifier Source: secondary_id
COG-AAML10B14
Identifier Type: OTHER
Identifier Source: secondary_id
AAML10B14
Identifier Type: OTHER
Identifier Source: secondary_id
AAML10B14
Identifier Type: OTHER
Identifier Source: secondary_id
AAML10B14
Identifier Type: -
Identifier Source: org_study_id
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