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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

May 6, 2010
January 28, 2011
February 2009
February 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01119560 on ClinicalTrials.gov Archive Site
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Genetic Biomarkers in Children With Neuroblastoma (Also Known as Neuroblastoma Epidemiology in North America [NENA])
Genetic Susceptibility Factors in the Etiology of Neuroblastoma (Also Known as Neuroblastoma Epidemiology in North America [NENA])

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.

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.
Observational
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Neuroblastoma
  • Genetic: DNA analysis
  • Genetic: cytogenetic analysis
  • Genetic: polymerase chain reaction
  • Genetic: polymorphism analysis
  • Other: questionnaire administration
  • Other: study of socioeconomic and demographic variables
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
600
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February 2012   (final data collection date for primary outcome measure)

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
Both
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Yes
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NCT01119560
CDR0000594334, COG-AEPI07N1
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Andrew F. Olshan, Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: Andrew F. Olshan, PhD UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP