Clinical trial NCT00897637: Gene Expression Profiles to Categorize Wilms Tumors
Official title: Categorization of Wilms Tumors by Genetic Expression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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)

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.

Eligibility criteria: 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

Primary outcomes:
measure: New molecular categories of Wilms tumor identified and measured by gene expression profiles
timeFrame: Up to 6 years
measure: Identification of genes that as a whole provide strong prediction of outcomes of interest
timeFrame: Up to 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Arcadia
country: United States
facility: Children's Oncology Group
state: California
city: West Palm Beach
country: United States
facility: Saint Mary's Hospital
state: Florida
Study officials:
affiliation: Children's Oncology Group
name: Elizabeth Perlman, MD
role: PRINCIPAL_INVESTIGATOR
References: