Gene Expression in Predicting Outcome in Samples From Patients With High-Risk Neuroblastoma
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Purpose
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 | Intervention |
|---|---|
|
Neuroblastoma |
Genetic: RNA analysis Genetic: gene expression analysis Other: laboratory biomarker analysis |
| Study Type: | Observational |
| Official Title: | Genome Based Outcome Prediction in High Risk Neuroblastoma |
- Linear correlation between the nCounter™ Analysis System and the expression data obtained in microarray platforms [ Designated as safety issue: No ]
- nCounter™ Analysis System and microarray platforms equally predictive of outcome in the high-risk group of neuroblastoma patients [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2012 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
More Information
Additional Information:
No publications provided
| Responsible Party: | Peter C. Adamson, Children's Oncology Group - Group Chair Office |
| ClinicalTrials.gov Identifier: | NCT01520233 History of Changes |
| Other Study ID Numbers: | CDR0000723895, COG-ANBL12B2 |
| Study First Received: | January 26, 2012 |
| Last Updated: | January 28, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
disseminated neuroblastoma localized unresectable neuroblastoma recurrent neuroblastoma regional neuroblastoma stage 4S neuroblastoma |
Additional relevant MeSH terms:
|
Neuroblastoma Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
ClinicalTrials.gov processed this record on May 16, 2013