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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01520233
Recruitment Status : Completed
First Posted : January 27, 2012
Last Update Posted : May 17, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:

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.

Condition or disease Intervention/treatment
Neuroblastoma Genetic: RNA analysis Genetic: gene expression analysis Other: laboratory biomarker analysis

Detailed Description:


  • 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.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Genome Based Outcome Prediction in High Risk Neuroblastoma
Study Start Date : January 2012
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Primary Outcome Measures :
  1. Linear correlation between the nCounter™ Analysis System and the expression data obtained in microarray platforms
  2. nCounter™ Analysis System and microarray platforms equally predictive of outcome in the high-risk group of neuroblastoma patients

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


  • 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


  • Not specified


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01520233

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
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Principal Investigator: Susan L. Cohn, MD University of Chicago Comer Children's Hospital

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Responsible Party: Children's Oncology Group Identifier: NCT01520233     History of Changes
Other Study ID Numbers: ANBL12B2
COG-ANBL12B2 ( Other Identifier: Children's Oncology Group )
CDR0000723895 ( Other Identifier: Clinical )
ANBL12B2 ( Other Identifier: Children's Oncology Group )
NCI-2012-00240 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: January 27, 2012    Key Record Dates
Last Update Posted: May 17, 2016
Last Verified: May 2016
Keywords provided by Children's Oncology Group:
disseminated neuroblastoma
localized unresectable neuroblastoma
recurrent neuroblastoma
regional neuroblastoma
stage 4S neuroblastoma
Additional relevant MeSH terms:
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Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue