Gene Expression Profiles to Categorize Wilms Tumors

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.

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Key information

Conditions

Recurrent Wilms Tumor and Other Childhood Kidney Tumors Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Complex and Mixed Neoplastic Syndromes, Hereditary Stage I Wilms Tumor Stage II Wilms Tumor Stage III Wilms Tumor Stage IV Wilms Tumor Stage V Wilms Tumor Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Wilms Tumor

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Oncology Group, Arcadia, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

New molecular categories of Wilms tumor identified and measured by gene expression profiles

Time frame: Up to 6 years
Identification of genes that as a whole provide strong prediction of outcomes of interest

Time frame: Up to 6 years

Supervised methods such as CART or Shrunken Centroid Classifier will be used.

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

Categorization of Wilms Tumors by Genetic Expression

Important dates

Study start: 2004
Primary completion: 2016
First posted: May 12, 2009
Registry last updated: May 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed