Genetic Susceptibility Biomarkers in Children With Neuroblastoma (Also Known as Neuroblastoma Epidemiology in North America [NENA])
- Conditions
- Neuroblastoma
- Registration Number
- NCT01119560
- Lead Sponsor
- Children's Oncology Group
- 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.
VII. Extract DNA from saliva samples and securely store. VIII. Clean new survey data and merge with main NENA study database.
OUTLINE:
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 polymerase chain reaction (PCR) quantitation assay, and genotyped using single nucleotide polymorphisms.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 576
- 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Gene-exposure interactions, with primary interest on folate, vitamin A, and choline intake, on the risk of NB 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 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) 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 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 Outcome Measures
Name Time Method
Trial Locations
- Locations (153)
Children's Hospital of Alabama
🇺🇸Birmingham, Alabama, United States
USA Health Strada Patient Care Center
🇺🇸Mobile, Alabama, United States
Phoenix Childrens Hospital
🇺🇸Phoenix, Arizona, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Kaiser Permanente Downey Medical Center
🇺🇸Downey, California, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Miller Children's and Women's Hospital Long Beach
🇺🇸Long Beach, California, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
Children's Hospital and Research Center at Oakland
🇺🇸Oakland, California, United States
Scroll for more (143 remaining)Children's Hospital of Alabama🇺🇸Birmingham, Alabama, United States