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

NCT ID: NCT00436696

Last Updated: 2018-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-12-11

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Localized Resectable Neuroblastoma Localized Unresectable Neuroblastoma Recurrent Neuroblastoma Regional Neuroblastoma Stage 4 Neuroblastoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Interventions

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Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Children's Oncology Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Maris

Role: PRINCIPAL_INVESTIGATOR

Children's Oncology Group

Locations

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University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

Childrens Oncology Group

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2009-00403

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000522985

Identifier Type: -

Identifier Source: secondary_id

COG-ANBL06B1

Identifier Type: -

Identifier Source: secondary_id

ANBL06B1

Identifier Type: -

Identifier Source: secondary_id

ANBL06B1

Identifier Type: OTHER

Identifier Source: secondary_id

ANBL06B1

Identifier Type: OTHER

Identifier Source: secondary_id

ANBL06B1

Identifier Type: -

Identifier Source: org_study_id

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