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

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ClinicalTrials.gov Identifier: NCT01119560
Recruitment Status : Active, not recruiting
First Posted : May 7, 2010
Last Update Posted : March 6, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Neuroblastoma Other: laboratory biomarker analysis Other: questionnaire administration

Detailed 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.


Study Design

Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Observational - Genetic Susceptibility Factors in the Etiology of Neuroblastoma Also Known as Neuroblastoma Epidemiology in North America (NENA)
Study Start Date : February 2012
Estimated Primary Completion Date : November 2032
Estimated Study Completion Date : November 2032

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Ancillary-Correlative (Questionnaire, saliva & tissue sample)
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: laboratory biomarker analysis
Correlative studies
Other: questionnaire administration
Ancillary studies


Outcome Measures

Primary Outcome Measures :
  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. Joint effects of multiple genes on the risk of NB [ Time Frame: Up to 4 years ]
  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.


Biospecimen Retention:   Samples With DNA
buccal cells

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with a primary diagnosis of neuroblastoma meeting other criteria.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01119560


Locations
United States, California
Children's Oncology Group
Monrovia, California, United States, 91006-3776
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Andrew Olshan, PhD Children's Oncology Group
More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01119560     History of Changes
Other Study ID Numbers: AEPI07N1
NCI-2011-02257 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
U10CA098543 ( U.S. NIH Grant/Contract )
COG-AEPI07N1 ( Other Identifier: Children's Oncology Group )
First Posted: May 7, 2010    Key Record Dates
Last Update Posted: March 6, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue