Gene Expression Profiles to Categorize Wilms Tumors

Study Overview
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Brief Summary
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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 Description
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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.

Official Title
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Categorization of Wilms Tumors by Genetic Expression

Conditions
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Recurrent Wilms Tumor and Other Childhood Kidney Tumors, Stage I Wilms Tumor, Stage II Wilms Tumor, Stage III Wilms Tumor, Stage IV Wilms Tumor, Stage V Wilms Tumor

Intervention / Treatment
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* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Specimens from patients previously enrolled as On Study or Followed Biology Only on protocol NWTSG-5 (COG-Q9401) Study follow-up data for disease status available National Wilms Tumor Study Group/Children's Oncology Group pathology review showing favorable histology Sufficient biology samples available without using biology bank reserves
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational<br>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. | Other: laboratory biomarker analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

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