Overview

This trial is active, not recruiting.

Condition neuroblastoma
Treatments laboratory biomarker analysis, questionnaire administration
Sponsor Children's Oncology Group
Collaborator National Cancer Institute (NCI)
Start date February 2012
End date November 2032
Trial size 700 participants
Trial identifier NCT01119560, AEPI07N1, COG-AEPI07N1, NCI-2011-02257, U10CA098543

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective retrospective
Arm
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.
laboratory biomarker analysis
Correlative studies
questionnaire administration
Ancillary studies

Primary Outcomes

Measure
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
Joint effects of multiple genes on the risk of NB
time frame: Up to 4 years
Gene-environment interactions
time frame: Up to 4 years
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

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Observational - Genetic Susceptibility Factors in the Etiology of Neuroblastoma Also Known as Neuroblastoma Epidemiology in North America (NENA)
Principal investigator Andrew Olshan, PhD
Description Study Subtype: Ancillary/Correlative Observational Study Model: Case-only Time Perspective: Prospective Biospecimen Retention: Samples With DNA Biospecimen Description: Saliva and Tissue Study Population Description: Patients already registered in ACCRN07 Sampling Method: Probability Sample 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, MYCN oncogene status, histology, and 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 MZ or 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Children's Oncology Group.