Study Results
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Basic Information
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COMPLETED
380 participants
OBSERVATIONAL
2010-07-31
2016-05-31
Brief Summary
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PURPOSE: This research study is studying biomarkers in young patients with neuroblastoma.
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Detailed Description
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Primary
* To discover the therapeutically relevant driver mutations in high-risk pediatric neuroblastoma.
Secondary
* To identify a set of highly annotated neuroblastoma specimens (primary tumors and cell lines) for comprehensive genomic analyses, validation studies, resequencing efforts, and future functional assays.
* To define genome-wide DNA copy number and allelic status in at least 300 high-risk and 50 low-risk neuroblastoma primary untreated tumors, and 30 human neuroblastoma-derived cell lines.
* To define the genome-wide methylation profile of neuroblastoma in a minimum of 200 high-risk cases.
* To define the genome-wide microRNA expression profile of neuroblastoma in a minimum of 200 high-risk cases.
* To define genome-wide RNA expression signatures, including splice variations, in the same tumors and cell lines studied above.
* To identify mutations in candidate therapeutic targets using a staged resequencing strategy with ultimate genome-scale next generation resequencing of 3 genomes for 200 high-risk cases: the neuroblastoma genome and transcriptome as well as the paired constitutional genome.
* To characterize the relapsed high-risk neuroblastoma genome and epigenome.
OUTLINE: This is a multicenter study.
Previously collected samples are analyzed to define the genome-wide DNA copy number and allelic status; to define the genome-wide methylation profile of high-risk neuroblastoma cases; to define the genome-wide microRNA expression profile of high-risk neuroblastoma cases; to define the genome-wide RNA expression and relating gene expression to DNA copy number and gene polymorphisms, DNA methylation, and microRNA expression; to resequence three genomes: the neuroblastoma genome, the transcriptome, and the paired constitutional genome; and to characterize the relapsed high-risk neuroblastoma genome and epigenome.
PROJECTED ACCRUAL: A total of 300 tumor samples from patients with high-risk disease, 50 tumor samples from patients with low-risk primary neuroblastoma, and 30 human neuroblastoma-derived cell lines will be accrued for this study.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Interventions
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DNA analysis
DNA methylation analysis
RNA analysis
comparative genomic hybridization
mutation analysis
polymorphism analysis
Eligibility Criteria
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Inclusion Criteria
* Registered on the COG-ANBL00B1 Neuroblastoma Biology Study or its CCG or POG precursor
* Sufficient high-quality tumor material available for the proposed studies meeting the following criteria:
* Tissue histopathologic review with \> 70% tumor cells in sections adjacent to areas used for nucleic acid preparation
* Matched normal cells (blood or uninvolved bone marrow) available
* ≥ 5 μg DNA available
* ≥ 5 μg RNA available
* ≥ 200 mg tissue available
* Tumor samples must meet 1 of the following criteria:
* High-risk tumor
* With or without MYCN amplification
* With or without tumor progression or relapse (during ≥ 2.5 years of follow up)
* Patients aged 18 months to 5 years
* Low-risk tumor
* Primary neuroblastoma
* Stage I disease (completely resected)
* No event in ≥ 3 years of follow up
* Cell lines representing diverse high-risk genetics including with or without MYCN amplification and clinical course (at diagnosis or after relapse)
PATIENT CHARACTERISTICS:
* Not specified
PRIOR CONCURRENT THERAPY:
* Not specified
30 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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John M. Maris, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Other Identifiers
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COG-ANBL10B1
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000681912
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2011-02246
Identifier Type: REGISTRY
Identifier Source: secondary_id
ANBL10B1
Identifier Type: -
Identifier Source: org_study_id
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