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Gene Expression Profiles to Categorize Wilms Tumors

Categorization of Wilms Tumors by Genetic Expression

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00897637
Enrollment
600
Registered
2009-05-12
Start date
2004-02-29
Completion date
Unknown
Last updated
2016-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Wilms Tumor and Other Childhood Kidney Tumors, Stage III Wilms Tumor, Stage II Wilms Tumor, Stage IV Wilms Tumor, Stage I Wilms Tumor, Stage V Wilms Tumor

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.

Interventions

OTHERlaboratory biomarker analysis

Correlative studies

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Children's Oncology Group
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
New molecular categories of Wilms tumor identified and measured by gene expression profilesUp to 6 years
Identification of genes that as a whole provide strong prediction of outcomes of interestUp to 6 yearsSupervised methods such as CART or Shrunken Centroid Classifier will be used.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026