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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01520233
First received: January 26, 2012
Last updated: May 7, 2015
Last verified: May 2015
  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
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Genome Based Outcome Prediction in High Risk Neuroblastoma

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • 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: January 2100 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01520233

Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Susan L. Cohn, MD University of Chicago Comer Children's Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01520233     History of Changes
Other Study ID Numbers: ANBL12B2, COG-ANBL12B2, CDR0000723895, ANBL12B2, NCI-2012-00240
Study First Received: January 26, 2012
Last Updated: May 7, 2015
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
disseminated neuroblastoma
localized unresectable neuroblastoma
recurrent neuroblastoma
regional neuroblastoma
stage 4S neuroblastoma

Additional relevant MeSH terms:
Neuroblastoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral

ClinicalTrials.gov processed this record on May 21, 2015