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Completed

NCT Number: NCT00958659

Study of Specimens From Young Patients With Neuroblastoma

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.

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Key information

Conditions

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

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Oncology Group

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  1. 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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Prognostic Multigene Expression Classification of Neuroblastoma Patients

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
Aug 13, 2009
Registry last updated
May 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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