Genetic Analysis Using Blood or Bone Marrow From Participants With Neuroblastoma or Noncancerous Conditions - Full Text View

Sponsors and Collaborators:	Children's Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00436696

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

MedlinePlus related topics: Cancer Neuroblastoma

U.S. FDA Resources

Study Type:	Observational
Official Title:	Genetic Basis of Neuroblastoma Tumorigenesis

Further study details as provided by National Cancer Institute (NCI):

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 ]

Estimated Enrollment:	9350
Study Start Date:	December 2006
Estimated Primary Completion Date:	November 2010 (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

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

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

Locations

United States, Mississippi
University of Mississippi Cancer Clinic	Recruiting
Jackson, Mississippi, United States, 39216-4505
Contact: Gail C. Megason 601-984-5220

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

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000522985, COG-ANBL06B1
Study First Received:	February 15, 2007
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00436696 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

disseminated neuroblastoma
localized resectable neuroblastoma
localized unresectable neuroblastoma
recurrent neuroblastoma
regional neuroblastoma

Study placed in the following topic categories:

Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Neuroectodermal Tumors, Primitive, Peripheral
Recurrence
Neuroblastoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neuroectodermal Tumors, Primitive
Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors, Primitive, Peripheral
Neuroblastoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009