Study of Specimens From Young Patients With Neuroblastoma

NCT ID: NCT00958659

Last Updated: 2016-05-18

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

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-12-31

Study Completion Date

2016-05-31

Brief Summary

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This research trial studies specimens from young patients with neuroblastoma. Studying the genes expressed in specimens from patients with cancer may help doctors identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

Detailed Description

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PRIMARY OBJECTIVES:

I. Establish a robust messenger ribonucleic acid (mRNA) gene expression classifier for improved outcome prediction in children with neuroblastoma by using real-time polymerase chain reaction (PCR) to quantify mRNA levels from genes that have been shown in at least 2 independent studies to have predictive power.

II. Identify microRNA (miRNA) patterns that have prognostic significance in neuroblastoma (NB) as accumulating evidence indicates that alterations in miRNA expression play a critical role in tumorigenesis and can be used in prognostic evaluation.

III. To perform an integrated analysis of the established microRNA classifier with our mRNA signature to determine whether it results in even better classification of NB tumors.

OUTLINE:

Previously collected samples are analyzed for 59 prognostic genes by real-time quantitative PCR-based gene expression profiling.

Conditions

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Localized Resectable Neuroblastoma Localized Unresectable Neuroblastoma Regional Neuroblastoma Stage 4S Neuroblastoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Ancillary-Correlative (gene expression profiling)

Previously collected samples are analyzed for 59 prognostic genes by real-time quantitative PCR-based gene expression profiling.

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

* Diagnosis of primary Neuroblastoma

* Untreated disease
* RNA samples from primary untreated NB-tumors available in Children's Oncology Group (COG) repository

* At least 60% tumor cells
* At least 2 years of follow-up from the date of diagnosis
* Full clinical and biological annotation
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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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Michael Hogarty, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Oncology Group

Locations

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Children's Oncology Group

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2011-02190

Identifier Type: REGISTRY

Identifier Source: secondary_id

COG-NB-2008-01

Identifier Type: OTHER

Identifier Source: secondary_id

ANBL08B1

Identifier Type: OTHER

Identifier Source: secondary_id

COG-ANBL08B1

Identifier Type: OTHER

Identifier Source: secondary_id

ANBL08B1

Identifier Type: -

Identifier Source: org_study_id

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