Gene Expression Profiles to Categorize Wilms Tumors

Recurrent Wilms Tumor and Other Childhood Kidney Tumors Clinical Trial

Official title:

Categorization of Wilms Tumors by Genetic Expression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00897637
• Other study ID #: AREN03B1
• Secondary ID: NCI-2009-00415CD
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: May 17, 2016
• Start date: February 2004

Study information

• Verified date: May 2016
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Kidney Neoplasms
• Neoplasms
• 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
• Wilms Tumor

Intervention

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Children's Oncology Group	Arcadia	California
United States	Saint Mary's Hospital	West Palm Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New molecular categories of Wilms tumor identified and measured by gene expression profiles		Up to 6 years	No
Primary	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	No