Trial Information

Categorization of Wilms Tumors by Genetic Expression

OBJECTIVES:

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

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

- 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.

- 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.

PROJECTED ACCRUAL: A total of 600 tumor tissue specimens from patients will be accrued for
this study.