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

Recurrent Neuroblastoma Clinical Trial

Official title:

Genetic Basis of Neuroblastoma Tumorigenesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00436696
• Other study ID #: ANBL06B1
• Secondary ID: NCI-2009-00403CD
• Status: Completed
• Start date: December 11, 2006

Study information

• Verified date: October 2017
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9350
• Est. primary completion date: May 5, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Childrens Oncology Group	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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