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NCT Number: NCT00436696

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

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.

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Key information

Conditions

Localized Resectable Neuroblastoma Localized Unresectable Neuroblastoma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroblastoma Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Recurrent Neuroblastoma Regional Neuroblastoma Stage 4 Neuroblastoma

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Mississippi Medical Center, Jackson, Mississippi, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  1. Neuroblastoma predisposition genes

    Time frame: Up to 4 years

  2. Single nucleotide polymorphism (SNP) allele disease association

    Time frame: Up to 4 years

  3. SNP haplotype disease association

    Time frame: Up to 4 years

  4. Validation of SNP allele and haplotype disease association

    Time frame: Up to 4 years

  5. SNP association with phenotypic subsets (i.e., high-risk vs no high-risk disease; MYCN amplification vs no MYCN amplification)

    Time frame: Up to 4 years

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Genetic Basis of Neuroblastoma Tumorigenesis

Important dates

Study start
2006
Primary completion
2016
First posted
Feb 19, 2007
Registry last updated
Aug 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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