Gene Expression Profiles to Categorize Wilms Tumors

Categorization of Wilms Tumors by Genetic Expression

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.

Study Overview

• Status: Completed
• Conditions: Recurrent Wilms Tumor and Other Childhood Kidney Tumors; Stage III Wilms Tumor; Stage IV Wilms Tumor; Stage V Wilms Tumor; Stage I Wilms Tumor; Stage II Wilms Tumor
• Intervention / Treatment: Other: laboratory biomarker analysis

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 Type: Observational
• Enrollment (Actual): 600

Contacts and Locations

Study Locations

• United States
  • California
    • Arcadia, California, United States, 91006-3776
      • Children's Oncology Group
  • Florida
    • West Palm Beach, Florida, United States, 33407
      • Saint Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Specimens from patients previously enrolled as "On Study" or "Followed Biology Only" on protocol NWTSG-5 (COG-Q9401)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational; 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; Correlative studies

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Children's Oncology Group
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start: February 1, 2004
• Primary Completion (ACTUAL): May 1, 2016

Study Registration Dates

• First Submitted: May 9, 2009
• First Submitted That Met QC Criteria: May 9, 2009
• First Posted (ESTIMATE): May 12, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): May 19, 2016
• Last Update Submitted That Met QC Criteria: May 17, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Genetic Diseases, Inborn; Neoplastic Syndromes, Hereditary; Neoplasms, Complex and Mixed; Neoplasms; Kidney Neoplasms; Wilms Tumor
• Other Study ID Numbers: AREN03B1; U10CA098543 (U.S. NIH Grant/Contract); NCI-2009-00415 (REGISTRY: CTRP (Clinical Trial Reporting Program)); CDR0000349184 (OTHER: Clinical Trials.gov); COG-AREN03B1 (OTHER: Children's Oncology Group)