Biomarkers in Young Patients With Neuroblastoma

Neuroblastoma Clinical Trial

Official title: Therapeutically Applicable Research to Generate Effective Treatments (TARGET) for Neuroblastoma

Status Completed

Clinical Trial Summary

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in young patients with neuroblastoma.

Clinical Trial Description

OBJECTIVES:

Primary

• To discover the therapeutically relevant driver mutations in high-risk pediatric neuroblastoma.

Secondary

• To identify a set of highly annotated neuroblastoma specimens (primary tumors and cell lines) for comprehensive genomic analyses, validation studies, resequencing efforts, and future functional assays.

• To define genome-wide DNA copy number and allelic status in at least 300 high-risk and 50 low-risk neuroblastoma primary untreated tumors, and 30 human neuroblastoma-derived cell lines.

• To define the genome-wide methylation profile of neuroblastoma in a minimum of 200 high-risk cases.

• To define the genome-wide microRNA expression profile of neuroblastoma in a minimum of 200 high-risk cases.

• To define genome-wide RNA expression signatures, including splice variations, in the same tumors and cell lines studied above.

• To identify mutations in candidate therapeutic targets using a staged resequencing strategy with ultimate genome-scale next generation resequencing of 3 genomes for 200 high-risk cases: the neuroblastoma genome and transcriptome as well as the paired constitutional genome.

• To characterize the relapsed high-risk neuroblastoma genome and epigenome.

OUTLINE: This is a multicenter study.

Previously collected samples are analyzed to define the genome-wide DNA copy number and allelic status; to define the genome-wide methylation profile of high-risk neuroblastoma cases; to define the genome-wide microRNA expression profile of high-risk neuroblastoma cases; to define the genome-wide RNA expression and relating gene expression to DNA copy number and gene polymorphisms, DNA methylation, and microRNA expression; to resequence three genomes: the neuroblastoma genome, the transcriptome, and the paired constitutional genome; and to characterize the relapsed high-risk neuroblastoma genome and epigenome.

PROJECTED ACCRUAL: A total of 300 tumor samples from patients with high-risk disease, 50 tumor samples from patients with low-risk primary neuroblastoma, and 30 human neuroblastoma-derived cell lines will be accrued for this study. ;

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Neuroblastoma

• NCT number: NCT01169376
• Study type: Observational
• Source: Children's Oncology Group
• Status: Completed
• Phase: N/A
• Start date: July 2010
• Completion date: May 2016