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Neuroblastoma Biology Studies

This study is currently recruiting participants.
Verified by Emory University, November 2005

Sponsored by: Emory University
Information provided by: Emory University
ClinicalTrials.gov Identifier: NCT00256763
  Purpose

Clinical and biological factors have been shown in previous studies to have prognostic value in neuroblastoma. Current therapeutic studies for neuroblastoma patients are tailored according to patient risk. In the Children’s Oncology Group (COG), risk-group assignment is currently based on the International Neuroblastoma Staging System (INSS) stage, age, MYCN copy number, tumor cell ploidy, and Shimada tumor histopathology. These biological features will be used for risk assignment and determination of therapy.

However, additional biologic factors have also been reported to be predictive of outcome in children with neuroblastoma. In this study, efforts will be made to analyze chromosome abnormalities such as 1p, 11q, 17q, TRK-A gene expression, telomerase (TRAP assay), and expression of the RNA component of telomerase (hTR). These latter features will not be used for risk assignment but their significance in regards to response to therapy and outcome will be analyzed in a prospective fashion. In addition, a reference bank containing genetically characterized frozen tumor tissue, tumor DNA and RNA, paired normal DNA and tumor cell lines for future research studies will be maintained.


Condition Intervention
Neuroblastoma
Procedure: Laboratory testing

MedlinePlus related topics:   Cancer    Neuroblastoma   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:   Neuroblastoma Biology Studies

Further study details as provided by Emory University:

Primary Outcome Measures:
  • Determine future therapies

Estimated Enrollment:   72
Study Start Date:   May 2001

Detailed Description:

Clinical and biological factors have been shown in previous studies to have prognostic value in neuroblastoma. Current therapeutic studies for neuroblastoma patients are tailored according to patient risk. In the Children’s Oncology Group (COG), risk-group assignment is currently based on the International Neuroblastoma Staging System (INSS) stage, age, MYCN copy number, tumor cell ploidy, and Shimada tumor histopathology. These biological features will be used for risk assignment and determination of therapy.

However, additional biologic factors have also been reported to be predictive of outcome in children with neuroblastoma. In this study, efforts will be made to analyze chromosome abnormalities such as 1p, 11q, 17q, TRK-A gene expression, telomerase (TRAP assay), and expression of the RNA component of telomerase (hTR). These latter features will not be used for risk assignment but their significance in regards to response to therapy and outcome will be analyzed in a prospective fashion. In addition, a reference bank containing genetically characterized frozen tumor tissue, tumor DNA and RNA, paired normal DNA and tumor cell lines for future research studies will be maintained.

  Eligibility
Ages Eligible for Study:   6 Months to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Neuroblastoma
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256763

Contacts
Contact: Dollicia David, BS     404-785-3633     Dollicia.David@choa.org    

Locations
United States, Georgia
Children's Healthcare of Atlanta     Recruiting
      Atlanta, Georgia, United States, 30322
      Contact: JoAnn Sadowski, BS     404-785-3531     JoAnn.Sadowski@choa.org    
      Principal Investigator: Carlos Alvardo, MD            

Sponsors and Collaborators
Emory University

Investigators
Principal Investigator:     Carlos Alvardo, MD     Children's Healthcare of Atlanta    
  More Information


Study ID Numbers:   128-2001
First Received:   November 18, 2005
Last Updated:   February 16, 2006
ClinicalTrials.gov Identifier:   NCT00256763
Health Authority:   United States: Institutional Review Board

Study placed in the following topic categories:
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroblastoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on September 19, 2008




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