Studying Gene Expression in Samples From Younger Patients With Neuroblastoma

Neuroblastoma Clinical Trial

Official title:

The Role of Stroma-Derived Soluble TßRIII in Neuroblastoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01553448
• Other study ID #: ANBL12B6
• Secondary ID: COG-ANBL12B6CDR0
• Status: Completed
• Phase: N/A
• First received: March 13, 2012
• Last updated: May 17, 2016
• Start date: March 2012

Study information

• Verified date: May 2016
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neoplasms
• Neoplastic Syndrome
• Neuroblastoma

Intervention

Genetic:
• gene expression analysis

• protein expression analysis

Other:
• enzyme-linked immunosorbent assay

• immunohistochemistry staining method

• laboratory biomarker analysis

• medical chart review

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression of TßRIII in the neuroblastic tumor and stroma of patients with advanced-stage NBL			No
Primary	Correlation between TßRIII levels and TGF-ß signaling correlate with NBL stage, tumor stroma content, surface TßRIII expression, and TGF-ß signaling			No

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database