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Prognostic Biomarkers in Tumor Tissue Samples From Young Patients With Neuroblastoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01358617
First received: May 19, 2011
Last updated: May 26, 2011
Last verified: May 2011
History of Changes
  Purpose

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify biomarkers and learn more about biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in tumor tissue samples from young patients with neuroblastoma.


Condition Intervention
Neuroblastoma
 Genetic: microarray analysis
Genetic: protein expression analysis
Other: immunoenzyme technique
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Expression of Ubiquitin Carboxyl-Terminal Hydrolase 1 (UCHL1) in Neuroblastoma Cancer Stem Cells and Its Relationship to Patient Prognosis

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:
  • UCHL1 as an indirect marker of cancer stem cells [ Designated as safety issue: No ]
  • UCHL1 as a biomarker of neuroblastoma prognosis [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: May 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine whether ubiquitin carboxyl-terminal hydrolase 1 (UCHL1) expression is an indirect cancer stem cell marker in pediatric patients with neuroblastoma.
  • Correlate UCHL1 expression with staging information and patient's outcome.

OUTLINE: Archived tissue microarray samples are analyzed for ubiquitin carboxyl-terminal hydrolase 1 (UCHL1) expression by UCHL1 monoclonal antibody and peroxidase technique. Results are then compared with patients' clinical data, including age at diagnosis, race, date of diagnosis, histology, stage and location at diagnosis, presence of cancer predisposition, date of completion of treatment, surgery performed, type of chemotherapy received, history of recurrence, and status (alive with disease, alive without disease, dead), if available.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosed with neuroblastoma
  • Tissue microarrays containing normal and neuroblastoma samples provided by the Children's Oncology Group (COG) Biopathology Center

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01358617

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Aaron Sugalski, MD University of Texas Health Science Center at San Antonio
  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

Responsible Party: Gregory H. Reaman, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT01358617     History of Changes
Other Study ID Numbers: CDR0000700618, COG-ANBL11B3
Study First Received: May 19, 2011
Last Updated: May 26, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
disseminated neuroblastoma
localized resectable neuroblastoma
recurrent neuroblastoma
stage 4S neuroblastoma
localized unresectable 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 19, 2013