Study of Specimens From Young Patients With Neuroblastoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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 2, 2014
Last verified: May 2014
  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
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:
  • Establishment of mRNA gene expression classifier [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • MicroRNA (miRNA) patterns that have prognostic significance in NB [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Better classification of NB tumors by analysis of the established microRNA classifier [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 321
Study Start Date: November 2008
Estimated Primary Completion Date: January 2100 (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
Sampling Method:   Non-Probability Sample
Study Population

Patients with a diagnosis of primary neuroblastoma meeting other criteria.

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
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
Childrens Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Michael Hogarty, MD    215-590-2821    hogartym@email.chop.edu   
Principal Investigator: Michael Hogarty, MD         
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Michael D. Hogarty, MD Children's Hospital of Philadelphia
  More Information

Additional Information:
No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00958659     History of Changes
Other Study ID Numbers: ANBL08B1, COG-NB-2008-01, NCI-2011-02190, CDR0000632128, COG-ANBL08B1
Study First Received: August 12, 2009
Last Updated: May 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Oncology Group:
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 August 26, 2014