Genetic Analysis Using Blood or Bone Marrow From Participants With Neuroblastoma or Noncancerous Conditions

August 3, 2018 updated by: Children's Oncology Group

Genetic Basis of Neuroblastoma Tumorigenesis

This laboratory study is looking at genes in participants with neuroblastoma or noncancerous conditions. Identifying genes related to cancer may help in the study of cancer. It may also help doctors predict who is at risk of developing neuroblastoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

I. Perform a whole genome scan for association of neuroblastoma with single nucleotide polymorphisms (SNP) and SNP haplotypes.

II. Identify true disease-associated SNP alleles using a customized genotyping platform enriched for haplotype analyses in an independent sample set.

III. Validate disease-associated SNP alleles and haplotypes in a final independent sample set.

IV. Identify neuroblastoma predisposition genes.

OUTLINE: This is a multicenter study. Participants are stratified according to presence of high-risk disease (yes vs no) and MYCN amplification (yes vs no).

DNA samples are derived from participants' banked blood or uninvolved bone marrow. A whole genome scan of DNA samples is employed to identify candidate single nucleotide polymorphisms (SNPs). The candidate SNPs are investigated, using a gene-centric haplotyping approach, to identify 10-20 true disease-associated alleles. The disease-associated alleles are again investigated, using a gene-centric haplotyping approach, to validate 5-10 disease-associated SNPs. SNPs are then analyzed for heritable predisposition.

Patients do not receive the results of the genetic testing. A certificate of confidentiality protecting the identity of research participants in this project has been issued by the Children's Oncology Group.

Study Type

Observational

Enrollment (Anticipated)

9350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Childrens Oncology Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Description

Inclusion Criteria:

  • Patient:

    • Diagnosis of neuroblastoma

      • Banked constitutional and genomic DNA within COG-ANBL00B1 Neuroblastoma Biology protocol or another COG Biology Protocol
      • At least 1.0 ?g of DNA available

  • Control (age, race, and gender-matched):

    • No diagnosis of cancer

    • May have other conditions, including any of the following:

      • Asthma
      • Inflammatory bowel disease
      • Attention-deficit disorder
      • Obesity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ancillary-correlative (SNP analysis)
DNA samples are derived from participants' banked blood or uninvolved bone marrow. A whole genome scan of DNA samples is employed to identify candidate single nucleotide polymorphisms (SNPs). The candidate SNPs are investigated, using a gene-centric haplotyping approach, to identify 10-20 true disease-associated alleles. The disease-associated alleles are again investigated, using a gene-centric haplotyping approach, to validate 5-10 disease-associated SNPs. SNPs are then analyzed for heritable predisposition.
Other: Laboratory Biomarker Analysis
Correlative studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neuroblastoma predisposition genes
Time Frame: Up to 4 years
Up to 4 years
Single nucleotide polymorphism (SNP) allele disease association
Time Frame: Up to 4 years
Up to 4 years
SNP haplotype disease association
Time Frame: Up to 4 years
Up to 4 years
Validation of SNP allele and haplotype disease association
Time Frame: Up to 4 years
Up to 4 years
SNP association with phenotypic subsets (i.e., high-risk vs no high-risk disease; MYCN amplification vs no MYCN amplification)
Time Frame: Up to 4 years
Up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: John Maris, Children's Oncology Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2006

Primary Completion (Actual)

May 5, 2016

Study Registration Dates

First Submitted

February 15, 2007

First Submitted That Met QC Criteria

February 15, 2007

First Posted (Estimate)

February 19, 2007

Study Record Updates

Last Update Posted (Actual)

August 7, 2018

Last Update Submitted That Met QC Criteria

August 3, 2018

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANBL06B1 (Other Identifier: CTEP)
  • NCI-2009-00403 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • CDR0000522985
  • COG-ANBL06B1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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