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

NCT ID: NCT01520233

Last Updated: 2016-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2016-05-31

Brief Summary

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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

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OBJECTIVES:

* To test the correlation of a previously published microarray gene expression signature with the gene expression obtained with the nCounterâ„¢ 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 nCounterâ„¢ 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.

Conditions

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Neuroblastoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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RNA analysis

Intervention Type GENETIC

gene expression analysis

Intervention Type GENETIC

laboratory biomarker analysis

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Children's Oncology Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susan L. Cohn, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago Comer Children's Hospital

Other Identifiers

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COG-ANBL12B2

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000723895

Identifier Type: OTHER

Identifier Source: secondary_id

ANBL12B2

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2012-00240

Identifier Type: REGISTRY

Identifier Source: secondary_id

ANBL12B2

Identifier Type: -

Identifier Source: org_study_id

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