An observational study in Neuroblastoma, sponsored by Children's Oncology Group. Completed at 153 sites in 2 countries. Per ClinicalTrials.gov, last updated 2019-01-08.
Sponsored by Children's Oncology Group · Observational
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.
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.
625 studies on the registry are indexed under Neuroblastoma; 122 are open to participants now.
This study's enrollment of 576 is above the median of 121 across 77 observational studies indexed under Neuroblastoma.
Browse Neuroblastoma studies →Children's Oncology Group is the lead sponsor of 436 studies on the registry; 34 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
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.
Other: Cytology Specimen Collection Procedure · Other: Laboratory Biomarker Analysis · Other: Questionnaire Administration
Correlative studies
Also known as: Cytologic Sampling
Correlative studies
Ancillary studies
Genetic polymorphisms involved in folate, vitamin A, and related metabolic and transport pathways with the risk of neuroblastoma (NB)
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.
Time frame: Up to 4 years
Gene-exposure interactions, with primary interest on folate, vitamin A, and choline intake, on the risk of NB
Stratified on the exposure variable and the strength of associations between strata by using a chi-square based test of heterogeneity.
Time frame: Up to 4 years
Gene-environment interactions
Stratified on the exposure variable and comparing the strength of associations between strata by using a chi-square-based test of heterogeneity.
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
Because the log-linear models involve calculating a likelihood, the Bayesian information criterion, a likelihood-based model selection criterion will be used.
Time frame: Up to 4 years
Showing the first 100 of 153 sites across 2 countries.
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Children's Oncology Group