Clinical trial NCT01553448: Studying Gene Expression in Samples From Younger Patients With Neuroblastoma
Official title: The Role of Stroma-Derived Soluble TßRIII in Neuroblastoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplastic Syndrome
Neuroblastoma
Keywords: disseminated neuroblastoma
hereditary neuroblastoma
localized resectable neuroblastoma
localized unresectable neuroblastoma
stage 4S neuroblastoma
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-03-14
Enrollment: 75
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

Brief summary: 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.

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 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

Primary outcomes:
measure: Expression of TβRIII in the neuroblastic tumor and stroma of patients with advanced-stage NBL
measure: Correlation between TβRIII levels and TGF-β signaling correlate with NBL stage, tumor stroma content, surface TβRIII expression, and TGF-β signaling
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Gerard C. Blobe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: