Study of Specimens From Young Patients With Neuroblastoma

Prognostic Multigene Expression Classification of Neuroblastoma Patients

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.

Study Overview

• Status: Completed
• Conditions: Localized Resectable Neuroblastoma; Localized Unresectable Neuroblastoma; Regional Neuroblastoma; Stage 4S Neuroblastoma
• Intervention / Treatment: Other: laboratory biomarker analysis

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 350

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Oncology Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients With Neuroblastoma

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ancillary-Correlative (gene expression profiling); Previously collected samples are analyzed for 59 prognostic genes by real-time quantitative PCR-based gene expression profiling.	Other: laboratory biomarker analysis; Correlative studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mRNA expression levels from genes that have been shown (in at least two independent studies) to have power for outcome prediction in children with NB, assessed by real-time PCR	Multivariate logistic regression analyses will be performed to determine if the mRNA expression signature is a significant independent predictor after controlling for currently used risk factors.	Baseline
miRNA patterns that have prognostic significance in NB, assessed by a reverse transcription quantitative PCR-based 'stem-loop' method to quantify expression levels	Multivariate logistic regression analyses will be performed to determine if the miRNA expression signature is a significant independent predictor after controlling for currently used risk factors.	Baseline

Collaborators and Investigators

• Sponsor: Children's Oncology Group
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Michael Hogarty, MD, Children's Oncology Group

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: August 12, 2009
• First Submitted That Met QC Criteria: August 12, 2009
• First Posted (Estimate): August 13, 2009

Study Record Updates

• Last Update Posted (Estimate): May 18, 2016
• Last Update Submitted That Met QC Criteria: May 16, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroectodermal Tumors, Primitive; Neuroectodermal Tumors, Primitive, Peripheral; Neuroblastoma
• Other Study ID Numbers: ANBL08B1 (Other Identifier: CTEP); NCI-2011-02190 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); COG-NB-2008-01 (Other Identifier: Children's Oncology Group); COG-ANBL08B1 (Other Identifier: Children's Oncology Group)