Genetic Analysis Using Blood or Bone Marrow From Participants With Neuroblastoma or Noncancerous Conditions
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|