Clinical trial NCT00436696: Genetic Analysis Using Blood or Bone Marrow From Participants With Neuroblastoma or Noncancerous Conditions
Official title: Genetic Basis of Neuroblastoma Tumorigenesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Localized Resectable Neuroblastoma
Localized Unresectable Neuroblastoma
Recurrent Neuroblastoma
Regional Neuroblastoma
Stage 4 Neuroblastoma
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-02-19
Enrollment: 9350
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Neuroblastoma predisposition genes
timeFrame: Up to 4 years
measure: Single nucleotide polymorphism (SNP) allele disease association
timeFrame: Up to 4 years
measure: SNP haplotype disease association
timeFrame: Up to 4 years
measure: Validation of SNP allele and haplotype disease association
timeFrame: Up to 4 years
measure: SNP association with phenotypic subsets (i.e., high-risk vs no high-risk disease; MYCN amplification vs no MYCN amplification)
timeFrame: Up to 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Philadelphia
country: United States
facility: Childrens Oncology Group
state: Pennsylvania
Study officials:
affiliation: Children's Oncology Group
name: John Maris
role: PRINCIPAL_INVESTIGATOR
References: