Genetic Analysis Using Blood or Bone Marrow From Participants With Neuroblastoma or Noncancerous Conditions
|ClinicalTrials.gov Identifier: NCT00436696|
Recruitment Status : Active, not recruiting
First Posted : February 19, 2007
Last Update Posted : October 9, 2017
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.
|Condition or disease||Intervention/treatment|
|Neuroblastoma||Genetic: gene mapping Genetic: polymorphism analysis|
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||9350 participants|
|Official Title:||Genetic Basis of Neuroblastoma Tumorigenesis|
|Study Start Date :||December 2006|
|Estimated Primary Completion Date :||January 2100|
- 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)
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00436696
|United States, Mississippi|
|University of Mississippi Cancer Clinic|
|Jackson, Mississippi, United States, 39216-4505|
|Study Chair:||John M. Maris, MD||Children's Hospital of Philadelphia|