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Genetic Biomarkers in Children With Neuroblastoma (Also Known as Neuroblastoma Epidemiology in North America [NENA])

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01119560
First received: May 6, 2010
Last updated: January 28, 2011
Last verified: January 2011
History of Changes
  Purpose

RATIONALE: Studying the genes in a child's cancer cells may help doctors improve ways to diagnose and treat children with neuroblastoma.

PURPOSE: This clinical trial is studying the genes biomarkers in children with neuroblastoma.


Condition Intervention
Neuroblastoma
 Genetic: DNA analysis
Genetic: cytogenetic analysis
Genetic: polymerase chain reaction
Genetic: polymorphism analysis
Other: questionnaire administration
Other: study of socioeconomic and demographic variables

Study Type: Observational
Official Title: Genetic Susceptibility Factors in the Etiology of Neuroblastoma (Also Known as Neuroblastoma Epidemiology in North America [NENA])

Resource links provided by NLM:

MedlinePlus related topics: Cancer Neuroblastoma
U.S. FDA Resources

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

Primary Outcome Measures:
  • Correlation of genetic polymorphisms involved in folate, vitamin A, and related metabolic and transport pathways with the risk of neuroblastoma (NB) [ Designated as safety issue: No ]
  • Joint effects of multiple genes on the risk of NB [ Designated as safety issue: No ]
  • Effects of gene-exposure interactions on the risk of NB [ Designated as safety issue: No ]
  • Genetic effects within specific NB subgroups [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: February 2009
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Evaluate the independent association of common genetic polymorphisms involved in folate, vitamin A, and related metabolic and transport pathways and the risk of neuroblastoma (NB) in children who were diagnosed before age 6.
  • Evaluate the joint effects of multiple genes on the risk of NB.
  • Evaluate the effects of gene-exposure interactions, with primary interest on folate, vitamin A, and choline intake, on the risk of NB.
  • Evaluate genetic effects within NB subgroups defined by age at diagnosis and a Children's Oncology group classification schema based on age, MYCN oncogene status, histology, and DNA ploidy.

OUTLINE: This is a multicenter study.

The biologic mother of the patient is asked to complete a Diet History Questionnaire about diet during pregnancy, and information on demographics, lifestyle factors, medication used during pregnancy, history of breast feeding, and family history of cancer or birth defects.

Parents are given ORAgene saliva collection kits for self-collection. Saliva bio-specimen samples are collected from both biologic parents and the patient. Tissue samples previously stored in a tissue bank are obtained for deceased patients, if available. DNA is extracted from samples, amplified and analyzed using real-time PCR quantitation assay, and genotyped using single nucleotide polymorphisms.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

DISEASE CHARACTERISTICS:

  • Primary diagnosis of neuroblastoma made at a North American COG institution
  • Diagnosed between 12/24/2007- 7/31/2013
  • Diagnosed at < 6 years of age
  • Biological mother is alive and willing to participate

PATIENT CHARACTERISTICS:

  • Questionnaire respondents must understand English or Spanish

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01119560

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Andrew F. Olshan, PhD UNC Lineberger Comprehensive Cancer Center
  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

Responsible Party: Andrew F. Olshan, Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
ClinicalTrials.gov Identifier: NCT01119560     History of Changes
Other Study ID Numbers: CDR0000594334, COG-AEPI07N1
Study First Received: May 6, 2010
Last Updated: January 28, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

ClinicalTrials.gov processed this record on May 19, 2013