Genetic Susceptibility Factors in the Etiology of Neuroblastoma Also Known as Neuroblastoma Epidemiology in North America (NENA)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Children's Oncology Group
- Enrollment
- 576
- Locations
- 153
- Primary Endpoint
- Gene-exposure interactions, with primary interest on folate, vitamin A, and choline intake, on the risk of NB
Study Overview
Brief Summary
This research trial studies the genes biomarkers in children with neuroblastoma. Studying the genes in a child's cancer cells may help doctors improve ways to diagnose and treat children with neuroblastoma.
Detailed Description
PRIMARY OBJECTIVES:
I. 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).
II. Evaluate the joint effects of multiple genes on the risk of NB. III. Evaluate the effects of gene-exposure interactions on the risk of NB. IV. Evaluate genetic effects within NB subgroups defined by age at diagnosis and a Children?s Oncology group classification schema based on age, v-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog (MYCN) oncogene status, histology, and deoxyribonucleic acid (DNA) ploidy.
V. Recontact mothers of participating NENA case children, conduct brief web-based screen to ascertain whether the pregnancy including the index NENA child was a multiple (twin, triplet, etc), whether the mother knew if the children were monozygotic (MZ) or dizygotic (DZ), and obtain a complete pregnancy history.
VI. Request a saliva sample from the other twin/multiple sibling of the NENA child.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
- •Questionnaire respondents must understand English or Spanish
- •Are only those participating in CCRN who have agreed to be contacted for future studies
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Gene-exposure interactions, with primary interest on folate, vitamin A, and choline intake, on the risk of NB
Time Frame: Up to 4 years
Stratified on the exposure variable and the strength of associations between strata by using a chi-square based test of heterogeneity.
Gene-environment interactions
Time Frame: Up to 4 years
Stratified on the exposure variable and comparing the strength of associations between strata by using a chi-square-based test of heterogeneity.
Genetic polymorphisms involved in folate, vitamin A, and related metabolic and transport pathways with the risk of neuroblastoma (NB)
Time Frame: Up to 4 years
The distributions of the estimated dietary and vitamin intake will be assessed and categories defined using quantiles and confirmation by nonparametric splines. Evaluated under a recessive or log-additive transmission model.
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 deoxyribonucleic acid (DNA) ploidy
Time Frame: Up to 4 years
Because the log-linear models involve calculating a likelihood, the Bayesian information criterion, a likelihood-based model selection criterion will be used.
Secondary Outcomes
No secondary outcomes reported