Gene Expression in Predicting Outcome in Samples From Patients With High-Risk Neuroblastoma

May 13, 2016 updated by: Children's Oncology Group

Genome Based Outcome Prediction in High Risk Neuroblastoma

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in RNA and predict how patients will respond to treatment. It may also help doctors find better ways to treat cancer.

PURPOSE: This research trial studies gene expression in predicting outcomes in samples from patients with high-risk neuroblastoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • To test the correlation of a previously published microarray gene expression signature with the gene expression obtained with the nCounter™ Analysis System using RNA isolated from formalin-fixed, paraffin-embedded (FFPE), high-risk neuroblastoma samples.
  • To construct, test, and validate a novel robust classifier that can be readily integrated into the clinic.

OUTLINE: This is a multicenter study.

RNA samples extracted from paraffin-embedded tissue are analyzed for gene signature expression levels by nCounter™ Analysis System and correlated with published microarray expression data. Results are then used to develop a refined gene-expression-profile classifier of ultra high-risk neuroblastoma.

Study Type

Observational

Enrollment (Actual)

100

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Neuroblastoma patients treated at the University of Chicago, St. Jude Children's Research Hospital, Children's Memorial Hospital, or Texas Children's Hospital.

Description

DISEASE CHARACTERISTICS:

  • Formalin-fixed paraffin-embedded tumor sections linked to clinical and outcome data collected from high-risk neuroblastoma patients (n=100) treated at the University of Chicago, St. Jude Children's Research Hospital, Children's Memorial Hospital, or Texas Children's Hospital

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
Linear correlation between the nCounter™ Analysis System and the expression data obtained in microarray platforms
nCounter™ Analysis System and microarray platforms equally predictive of outcome in the high-risk group of neuroblastoma patients

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)

Investigators

  • Principal Investigator: Susan L. Cohn, MD, University of Chicago Comer Children's Hospital

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

January 1, 2012

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

January 26, 2012

First Submitted That Met QC Criteria

January 26, 2012

First Posted (Estimate)

January 27, 2012

Study Record Updates

Last Update Posted (Estimate)

May 17, 2016

Last Update Submitted That Met QC Criteria

May 13, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANBL12B2 (Other Identifier: Children's Oncology Group)
  • COG-ANBL12B2 (Other Identifier: Children's Oncology Group)
  • CDR0000723895 (Other Identifier: Clinical Trials.gov)
  • NCI-2012-00240 (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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