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Completed

NCT Number: NCT01119560

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

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.

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Key information

Conditions

Neuroblastoma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral

Sex eligibility

All sexes

Study type

Observational

Primary location

Alberta Children's Hospital, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cytology Specimen Collection Procedure

Other

Correlative studies

Other names: Cytologic Sampling

laboratory biomarker analysis

Other

Correlative studies

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2018
Study completion
2018
First posted
May 7, 2010
Registry last updated
Jan 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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