Clinical Trial: Genetic Analysis Using Blood or Bone Marrow From Participants With Neuroblastoma or Noncancerous Conditions
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational
Official Title: Genetic Basis of Neuroblastoma Tumorigenesis
Brief Summary:
RATIONALE: 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.
PURPOSE: This laboratory study is looking at genes in participants with neuroblastoma or noncancerous conditions.
Detailed Summary:
OBJECTIVES:
- Perform a whole genome scan for association of neuroblastoma with single nucleotide polymorphisms (SNP) and SNP haplotypes.
- Identify true disease-associated SNP alleles using a customized genotyping platform enriched for haplotype analyses in an independent sample set.
- Validate disease-associated SNP alleles and haplotypes in a final independent sample set.
- 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.
PROJECTED ACCRUAL: A total of 4,675 patients and 4,675 controls will be accrued for this study.
Sponsor: Children's Oncology Group
Current Primary Outcome:
- Neuroblastoma predisposition genes
- Single nucleotide polymorphism (SNP) allele disease association
- SNP haplotype disease association
- Validation of SNP allele and haplotype disease association
- SNP association with phenotypic subsets (i.e., high-risk vs no high-risk disease; MYCN amplification vs no MYCN amplification)
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Children's Oncology Group
Dates:
Date Received: February 15, 2007
Date Started: December 2006
Date Completion:
Last Updated: October 4, 2016
Last Verified: October 2016