跳至主要内容
临床试验/NCT01119560
NCT01119560已完成不适用

Genetic Susceptibility Factors in the Etiology of Neuroblastoma Also Known as Neuroblastoma Epidemiology in North America (NENA)

Children's Oncology Group153 个研究点 分布在 1 个国家目标入组 576 人开始时间: 2009年2月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
576
试验地点
153
主要终点
Gene-exposure interactions, with primary interest on folate, vitamin A, and choline intake, on the risk of NB

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

Gene-exposure interactions, with primary interest on folate, vitamin A, and choline intake, on the risk of NB

时间窗: 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

时间窗: 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)

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (153)

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