Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:25 AM
Study NCT ID:
NCT01520233
Status:
COMPLETED
Last Update Posted:
2016-05-17
First Post:
2012-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gene Expression in Predicting Outcome in Samples From Patients With High-Risk Neuroblastoma
Sponsor:
Children's Oncology Group
Organization:
Study Overview
Official Title:
Genome Based Outcome Prediction in High Risk Neuroblastoma
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: