Clinical Trial: Gene Expression Profiles to Categorize Wilms Tumors

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Categorization of Wilms Tumors by Genetic Expression

Brief Summary: This laboratory study is using gene expression profiling to identify different categories of Wilms tumors. Studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer.

Detailed Summary:

OBJECTIVES:

I. Identify new molecular categories of Wilms tumor (WT) based on the gene expression profiles of samples from patients with this disease.

II. Develop a classifying system (classifier) that will predict a defined number of clinically relevant categories based on expression of an established set of genes.

III. Confirm and test the classifier with further analysis of the genes by several different methodologies, using additional patient samples that are outside of the case/cohort but which possess the clinically or scientifically relevant parameter.

IV. Validate the use of the classifier to predict defined groups within a second set of samples (for which investigators are blinded to the clinical and biological data) by subsequent comparison with true incidence of pertinent markers.

OUTLINE:

Three hundred tumor specimens are analyzed for genetic expression profiles using Affymetrix assays. Specific genes are identified as classifiers and analyzed using tissue arrays. An additional 300 specimens are examined for gene expression and categorized according to the classifiers.


Sponsor: Children's Oncology Group

Current Primary Outcome:

  • New molecular categories of Wilms tumor identified and measured by gene expression profiles [ Time Frame: Up to 6 years ]
  • Identification of genes that as a whole provide strong prediction of outcomes of interest [ Time Frame: Up to 6 years ]
    Supervised methods such as CART or Shrunken Centroid Classifier will be used.


Original Primary Outcome:

  • New molecular categories of Wilms tumor identified and measured by gene expression profiles
  • Development of a classifying system that will predict a defined number of clinically relevant categories based on expression of an established set of genes
  • Confirm and test the classifying system with further gene analysis by different methodologies
  • Validation of the classifying system


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Children's Oncology Group

Dates:
Date Received: May 9, 2009
Date Started: February 2004
Date Completion:
Last Updated: May 17, 2016
Last Verified: May 2016