Biomarkers in Young Patients With Neuroblastoma

May 17, 2016 updated by: Children's Oncology Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Observational

Enrollment (Anticipated)

380

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

No older than 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients registered on the COG-ANBL00B1 Neuroblastoma Biology Study

Description

DISEASE CHARACTERISTICS:

  • Registered on the COG-ANBL00B1 Neuroblastoma Biology Study or its CCG or POG precursor

  • Sufficient high-quality tumor material available for the proposed studies meeting the following criteria:

    • Tissue histopathologic review with > 70% tumor cells in sections adjacent to areas used for nucleic acid preparation
    • Matched normal cells (blood or uninvolved bone marrow) available
    • ≥ 5 μg DNA available
    • ≥ 5 μg RNA available
    • ≥ 200 mg tissue available

  • Tumor samples must meet 1 of the following criteria:

    • High-risk tumor

      • With or without MYCN amplification
      • With or without tumor progression or relapse (during ≥ 2.5 years of follow up)
      • Patients aged 18 months to 5 years

    • Low-risk tumor

      • Primary neuroblastoma
      • Stage I disease (completely resected)
      • No event in ≥ 3 years of follow up
    • Cell lines representing diverse high-risk genetics including with or without MYCN amplification and clinical course (at diagnosis or after relapse)

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Discovery of therapeutically relevant driver mutations

Secondary Outcome Measures

Outcome Measure
Identification of a set of neuroblastoma specimens for analyses
Genome-wide DNA copy number and allelic status
Genome-wide methylation profile
Genome-wide microRNA expression profile
Genome-wide RNA expression signatures
Identification of mutations in candidate therapeutic targets
Characterization of the relapsed high-risk neuroblastoma genome and epigenome

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)

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

July 1, 2010

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

July 23, 2010

First Submitted That Met QC Criteria

July 23, 2010

First Posted (Estimate)

July 26, 2010

Study Record Updates

Last Update Posted (Estimate)

May 18, 2016

Last Update Submitted That Met QC Criteria

May 17, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANBL10B1
  • COG-ANBL10B1 (Other Identifier: Children's Oncology Group)
  • CDR0000681912 (Other Identifier: Clinical Trials.gov)
  • NCI-2011-02246 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

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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