Studying Gene Expression in Samples From Younger Patients With Neuroblastoma

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01553448
First received: March 13, 2012
Last updated: May 17, 2016
Last verified: May 2016
  Purpose

RATIONALE: Studying samples of blood and 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. It may also help doctors find better ways to treat cancer.

PURPOSE: This research trial studies gene expression in samples from younger patients with neuroblastoma.


Condition Intervention
Neoplastic Syndrome
Neuroblastoma
Genetic: gene expression analysis
Genetic: protein expression analysis
Other: enzyme-linked immunosorbent assay
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: medical chart review

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Role of Stroma-Derived Soluble TßRIII in Neuroblastoma

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Expression of TβRIII in the neuroblastic tumor and stroma of patients with advanced-stage NBL [ Designated as safety issue: No ]
  • Correlation between TβRIII levels and TGF-β signaling correlate with NBL stage, tumor stroma content, surface TβRIII expression, and TGF-β signaling [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: March 2012
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine whether TβRIII expression and TGF-β signaling decrease in advanced-stage neuroblastoma (NBL) and whether these changes are confined to the Schwannian stroma.
  • Determine whether sTβRIII levels and TGF-β signaling correlate with NBL stage, tumor stroma content, surface TβRIII expression, and TGF-β signaling.

OUTLINE: Archived paraffin-embedded tissue and plasma samples are analyzed for TβRIII expression, TGF-β signaling, and SMAD3 expression and phosphorylation by immunohistochemistry, enzyme-linked immunosorbent assay (ELISA), and other assays. Surface expression of TβRIII in the neuroblastic and stromal tumor components are correlated with matched circulating levels of soluble TβRIII. Results are then correlated with each patient's outcome data, including stage.

  Eligibility

Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with low-stage (International Neuroblastoma Staging System [INSS] stage 1 or 2) neuroblastoma (NBL), patients with advanced-stage (INSS stage 3 or 4) NBL, or patients with stage 4S NBL
Criteria

DISEASE CHARACTERISTICS:

  • Tissue samples and matched plasma samples available from 1 of the following groups:

    • Patients with low-stage (International Neuroblastoma Staging System [INSS] stage 1 or 2) neuroblastoma (NBL)
    • Patients with advanced-stage (INSS stage 3 or 4) NBL
    • Patients with stage 4S NBL
  • Clinical and/or outcome data associated with the tissue and plasma samples including INSS stage, age, MYCN amplification status, chromosomal alterations, and 5-year survival, if known

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01553448

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Gerard C. Blobe, MD, PhD Duke University
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01553448     History of Changes
Other Study ID Numbers: ANBL12B6  COG-ANBL12B6  CDR0000728527  ANBL12B6  NCI-2012-00706 
Study First Received: March 13, 2012
Last Updated: May 17, 2016
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
disseminated neuroblastoma
hereditary neuroblastoma
localized resectable neuroblastoma
localized unresectable neuroblastoma
stage 4S neuroblastoma

Additional relevant MeSH terms:
Neuroblastoma
Neoplasms
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on August 30, 2016