Study of Specimens From Young Patients With Neuroblastoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00958659
First received: August 12, 2009
Last updated: May 11, 2015
Last verified: May 2015
  Purpose

This research trial studies specimens from young patients with neuroblastoma. Studying the genes expressed in specimens from patients with cancer may help doctors identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.


Condition Intervention
Localized Resectable Neuroblastoma
Localized Unresectable Neuroblastoma
Regional Neuroblastoma
Stage 4S Neuroblastoma
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Prognostic Multigene Expression Classification of Neuroblastoma Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • mRNA expression levels from genes that have been shown (in at least two independent studies) to have power for outcome prediction in children with NB, assessed by real-time PCR [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Multivariate logistic regression analyses will be performed to determine if the mRNA expression signature is a significant independent predictor after controlling for currently used risk factors.

  • miRNA patterns that have prognostic significance in NB, assessed by a reverse transcription quantitative PCR-based 'stem-loop' method to quantify expression levels [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Multivariate logistic regression analyses will be performed to determine if the miRNA expression signature is a significant independent predictor after controlling for currently used risk factors.


Estimated Enrollment: 350
Study Start Date: December 2008
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ancillary-Correlative (gene expression profiling)
Previously collected samples are analyzed for 59 prognostic genes by real-time quantitative PCR-based gene expression profiling.
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. Establish a robust messenger ribonucleic acid (mRNA) gene expression classifier for improved outcome prediction in children with neuroblastoma by using real-time polymerase chain reaction (PCR) to quantify mRNA levels from genes that have been shown in at least 2 independent studies to have predictive power.

II. Identify microRNA (miRNA) patterns that have prognostic significance in neuroblastoma (NB) as accumulating evidence indicates that alterations in miRNA expression play a critical role in tumorigenesis and can be used in prognostic evaluation.

III. To perform an integrated analysis of the established microRNA classifier with our mRNA signature to determine whether it results in even better classification of NB tumors.

OUTLINE:

Previously collected samples are analyzed for 59 prognostic genes by real-time quantitative PCR-based gene expression profiling.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients With Neuroblastoma

Criteria

Inclusion Criteria:

  • Diagnosis of primary Neuroblastoma

    • Untreated disease
  • RNA samples from primary untreated NB-tumors available in Children's Oncology Group (COG) repository

    • At least 60% tumor cells
  • At least 2 years of follow-up from the date of diagnosis
  • Full clinical and biological annotation
  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: NCT00958659

Locations
United States, Pennsylvania
Children's Oncology Group Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Michael D. Hogarty, MD    215-590-3931    hogartym@email.chop.edu   
Principal Investigator: Michael D. Hogarty, MD         
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Michael Hogarty, MD Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00958659     History of Changes
Other Study ID Numbers: ANBL08B1, NCI-2011-02190, COG-NB-2008-01, ANBL08B1, COG-ANBL08B1
Study First Received: August 12, 2009
Last Updated: May 11, 2015
Health Authority: United States: Institutional Review Board

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