Biomarkers in Tumor Samples From Younger Patients With Neuroblastoma

July 7, 2016 updated by: Children's Oncology Group

Proposed Studies on the Role of Growth Factor Receptor Trafficking in Neuroblastoma Pathogenesis

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

PURPOSE: This research trial studies biomarkers in tumor samples from younger patients with neuroblastoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • To determine the expression of UBE4B, hrs, and members of the ubiquitination protein complex in previously banked primary neuroblastoma tumor samples from the Children's Oncology Group.
  • To determine the correlation of expression levels and cellular localization of the UBE4B and hrs proteins with growth factor-receptor tumor cell-surface expression.
  • To determine the 1p36 deletion status by fluorescence in situ hybridization (FISH) analysis and their association with expression levels of UBE4B and hrs in previously banked primary neuroblastoma tumor samples from the Children's Oncology Group.

OUTLINE: Banked tumor tissue samples are analyzed for expression of UBE4B, hrs, members of the ubiquitination protein complex, growth factor receptors, and 1p36 deletion status by immunohistochemistry (IHC), fluorescent microscopy, and fluorescence in situ hybridization (FISH).

Study Type

Observational

Enrollment (Anticipated)

5

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 116 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients With Neuroblastoma

Description

DISEASE CHARACTERISTICS:

  • Tumor tissue microarrays from the Children's Oncology Group neuroblastoma tumor bank

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Expression of UBE4B, hrs, and members of the ubiquitination protein complex
Expression levels and cellular localization of the UBE4B, hrs, and growth factor receptors
1p36 deletion status and its association with UBE4B

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Peter Zage, MD, PhD, Texas Children's Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

December 15, 2011

First Submitted That Met QC Criteria

December 15, 2011

First Posted (Estimate)

December 16, 2011

Study Record Updates

Last Update Posted (Estimate)

July 11, 2016

Last Update Submitted That Met QC Criteria

July 7, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANBL12B4 (Other Identifier: Children's Oncology Group)
  • COG-ANBL12B4 (Other Identifier: Children's Oncology Group)
  • NCI-2012-00091 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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