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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00436696
First Posted: February 19, 2007
Last Update Posted: October 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
  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
  • 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
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 120 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


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

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00436696     History of Changes
Other Study ID Numbers: ANBL06B1
COG-ANBL06B1 ( Other Identifier: Children's Oncology Group )
NCI-2009-00403 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: February 15, 2007
First Posted: February 19, 2007
Last Update Posted: October 9, 2017
Last Verified: October 2017

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

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