Gene Expression Profiles to Categorize Wilms Tumors

Completed

• Conditions: Stage IV Wilms Tumor; Stage I Wilms Tumor; Recurrent Wilms Tumor and Other Childhood Kidney Tumors; Stage III Wilms Tumor; Stage V Wilms Tumor; Stage II Wilms Tumor
• Interventions: Other: laboratory biomarker analysis

• Registration Number: NCT00897637
• Lead Sponsor: Children's Oncology Group

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 Description

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.

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Last Update Submitted: 2016-05-17
• Last Update Posted: 2016-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	laboratory biomarker analysis	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.

Primary Outcome Measures

Name	Time	Method
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	Up to 6 years	Supervised methods such as CART or Shrunken Centroid Classifier will be used.

Trial Locations

Locations (2)

Saint Mary's Hospital; 🇺🇸 West Palm Beach, Florida, United States

Children's Oncology Group; 🇺🇸 Arcadia, California, United States