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Genetic Analysis Using Blood or Bone Marrow From Participants With Neuroblastoma or Noncancerous Conditions

Completed
Conditions
Recurrent Neuroblastoma
Localized Unresectable Neuroblastoma
Regional Neuroblastoma
Stage 4 Neuroblastoma
Localized Resectable Neuroblastoma
Interventions
Other: Laboratory Biomarker Analysis
Registration Number
NCT00436696
Lead Sponsor
Children's Oncology Group
Brief Summary

This laboratory study is looking at genes in participants with neuroblastoma or noncancerous conditions. Identifying genes related to cancer may help in the study of cancer. It may also help doctors predict who is at risk of developing neuroblastoma.

Detailed Description

OBJECTIVES:

I. Perform a whole genome scan for association of neuroblastoma with single nucleotide polymorphisms (SNP) and SNP haplotypes.

II. Identify true disease-associated SNP alleles using a customized genotyping platform enriched for haplotype analyses in an independent sample set.

III. Validate disease-associated SNP alleles and haplotypes in a final independent sample set.

IV. Identify neuroblastoma predisposition genes.

OUTLINE: This is a multicenter study. Participants are stratified according to presence of high-risk disease (yes vs no) and MYCN amplification (yes vs no).

DNA samples are derived from participants' banked blood or uninvolved bone marrow. A whole genome scan of DNA samples is employed to identify candidate single nucleotide polymorphisms (SNPs). The candidate SNPs are investigated, using a gene-centric haplotyping approach, to identify 10-20 true disease-associated alleles. The disease-associated alleles are again investigated, using a gene-centric haplotyping approach, to validate 5-10 disease-associated SNPs. SNPs are then analyzed for heritable predisposition.

Patients do not receive the results of the genetic testing. A certificate of confidentiality protecting the identity of research participants in this project has been issued by the Children's Oncology Group.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
9350
Inclusion Criteria
  • Patient:

    • Diagnosis of neuroblastoma

      • Banked constitutional and genomic DNA within COG-ANBL00B1 Neuroblastoma Biology protocol or another COG Biology Protocol
      • At least 1.0 ?g of DNA available
  • Control (age, race, and gender-matched):

    • No diagnosis of cancer

    • May have other conditions, including any of the following:

      • Asthma
      • Inflammatory bowel disease
      • Attention-deficit disorder
      • Obesity
Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Ancillary-correlative (SNP analysis)Laboratory Biomarker AnalysisDNA samples are derived from participants' banked blood or uninvolved bone marrow. A whole genome scan of DNA samples is employed to identify candidate single nucleotide polymorphisms (SNPs). The candidate SNPs are investigated, using a gene-centric haplotyping approach, to identify 10-20 true disease-associated alleles. The disease-associated alleles are again investigated, using a gene-centric haplotyping approach, to validate 5-10 disease-associated SNPs. SNPs are then analyzed for heritable predisposition.
Primary Outcome Measures
NameTimeMethod
Neuroblastoma predisposition genesUp to 4 years
Single nucleotide polymorphism (SNP) allele disease associationUp to 4 years
SNP haplotype disease associationUp to 4 years
Validation of SNP allele and haplotype disease associationUp to 4 years
SNP association with phenotypic subsets (i.e., high-risk vs no high-risk disease; MYCN amplification vs no MYCN amplification)Up to 4 years
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

Childrens Oncology Group

🇺🇸

Philadelphia, Pennsylvania, United States

University of Mississippi Medical Center

🇺🇸

Jackson, Mississippi, United States

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