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

Genome Based Outcome Prediction in High Risk Neuroblastoma

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01520233

Enrollment

100

Registered

2012-01-27

Start date

2012-01-31

Completion date

2016-05-31

Last updated

2016-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroblastoma

Keywords

disseminated neuroblastoma, localized unresectable neuroblastoma, recurrent neuroblastoma, regional neuroblastoma, stage 4S neuroblastoma

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.

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.

Interventions

GENETICRNA analysis

GENETICgene expression analysis

OTHERlaboratory biomarker analysis

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026