NCT00436696

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,350

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 11, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 19, 2007

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2016

Completed
Last Updated

August 7, 2018

Status Verified

October 1, 2017

Enrollment Period

9.4 years

First QC Date

February 15, 2007

Last Update Submit

August 3, 2018

Conditions

Outcome Measures

Primary Outcomes (5)

  • Neuroblastoma predisposition genes

    Up to 4 years

  • Single nucleotide polymorphism (SNP) allele disease association

    Up to 4 years

  • SNP haplotype disease association

    Up to 4 years

  • Validation of SNP allele and haplotype disease association

    Up to 4 years

  • SNP association with phenotypic subsets (i.e., high-risk vs no high-risk disease; MYCN amplification vs no MYCN amplification)

    Up to 4 years

Study Arms (1)

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

Interventions

Correlative studies

Ancillary-correlative (SNP analysis)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Childrens Oncology Group

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Bone Marrow

MeSH Terms

Conditions

Neuroblastoma

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • John Maris

    Children's Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2007

First Posted

February 19, 2007

Study Start

December 11, 2006

Primary Completion

May 5, 2016

Last Updated

August 7, 2018

Record last verified: 2017-10

Locations