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Study of Specimens From Young Patients With Neuroblastoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00958659
First received: August 12, 2009
Last updated: September 10, 2009
Last verified: September 2009
History of Changes
  Purpose

RATIONALE: 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.

PURPOSE: This research study is looking at specimens from young patients with neuroblastoma.


Condition Intervention
Neuroblastoma
 Genetic: gene expression analysis
Genetic: polymerase chain reaction
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Prognostic Multigene Expression Classification of Neuroblastoma Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer Neuroblastoma
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Establishment of mRNA gene expression classifier [ Designated as safety issue: No ]
  • MicroRNA (miRNA) patterns that have prognostic significance in NB [ Designated as safety issue: No ]
  • Better classification of NB tumors by analysis of the established microRNA classifier [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: November 2008
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Establish a robust mRNA gene expression classifier for improved outcome prediction in children with neuroblastoma by using real-time PCR to quantify mRNA levels from genes that have been shown in ≥ 2 independent studies to have predictive power.
  • Identify microRNA (miRNA) patterns that have prognostic significance in NB as accumulating evidence indicates that alterations in miRNA expression play a critical role in tumorigenesis and can be used in prognostic evaluation.
  • 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: Samples are analyzed for 59 prognostic genes by real-time quantitative PCR-based gene expression profiling.

PROJECTED ACCRUAL: A total of 150 samples from high-risk patients, 100 samples from medium-risk patients, and 100 samples from low-risk patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of primary neuroblastoma (NB)

    • Untreated disease

  • RNA samples from primary untreated NB-tumors available in COG repository

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

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00958659

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Michael D. Hogarty, MD Children's Hospital of Philadelphia
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00958659     History of Changes
Other Study ID Numbers: CDR0000632128, COG-NB-2008-01
Study First Received: August 12, 2009
Last Updated: September 10, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
localized resectable neuroblastoma
localized unresectable 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 23, 2013