Study of Specimens From Young Patients With Neuroblastoma

Completed

• Conditions: Localized Resectable Neuroblastoma; Stage 4S Neuroblastoma; Regional Neuroblastoma; Localized Unresectable Neuroblastoma
• Interventions: Other: laboratory biomarker analysis

• Registration Number: NCT00958659
• Lead Sponsor: Children's Oncology Group

Brief Summary

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

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 Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-08-12
• Study First Submitted QC: 2009-08-12
• Study First Posted: 2009-08-13
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-16
• Last Update Posted: 2016-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ancillary-Correlative (gene expression profiling)	laboratory biomarker analysis	Previously collected samples are analyzed for 59 prognostic genes by real-time quantitative PCR-based gene expression profiling.

Primary Outcome Measures

Name	Time	Method
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	Baseline	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.
miRNA patterns that have prognostic significance in NB, assessed by a reverse transcription quantitative PCR-based 'stem-loop' method to quantify expression levels	Baseline	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.

Trial Locations

Locations (1)

Children's Oncology Group; 🇺🇸 Philadelphia, Pennsylvania, United States