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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00436696
First received: February 15, 2007
Last updated: May 11, 2015
Last verified: May 2015
  Purpose

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 Intervention
Neuroblastoma
Genetic: gene mapping
Genetic: polymorphism analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Genetic Basis of Neuroblastoma Tumorigenesis

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Neuroblastoma predisposition genes [ Designated as safety issue: No ]
  • Single nucleotide polymorphism (SNP) allele disease association [ Designated as safety issue: No ]
  • SNP haplotype disease association [ Designated as safety issue: No ]
  • Validation of SNP allele and haplotype disease association [ Designated as safety issue: No ]
  • SNP association with phenotypic subsets (i.e., high-risk vs no high-risk disease; MYCN amplification vs no MYCN amplification) [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood, Bone Marrow


Estimated Enrollment: 9350
Study Start Date: December 2006
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Participants With Neuroblastoma or Noncancerous Conditions

Criteria

DISEASE CHARACTERISTICS:

  • Patient:

    • Diagnosis of neuroblastoma

      • Banked constitutional and genomic DNA within COG-ANBL00B1 Neuroblastoma Biology protocol or another COG Biology Protocol
      • At least 1.0 μg 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

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00436696

Locations
United States, Mississippi
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States, 39216-4505
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: John M. Maris, MD Children's Hospital of Philadelphia
  More Information

Additional Information:
No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00436696     History of Changes
Other Study ID Numbers: ANBL06B1, COG-ANBL06B1, NCI-2009-00403
Study First Received: February 15, 2007
Last Updated: May 11, 2015
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
disseminated neuroblastoma
localized resectable neuroblastoma
localized unresectable neuroblastoma
recurrent neuroblastoma
regional neuroblastoma

Additional relevant MeSH terms:
Neuroblastoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral

ClinicalTrials.gov processed this record on August 30, 2015