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Gene Expression Profiles to Categorize Wilms Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00897637
First received: May 9, 2009
Last updated: February 19, 2014
Last verified: February 2014

May 9, 2009
February 19, 2014
February 2004
January 2100   (final data collection date for primary outcome measure)
  • New molecular categories of Wilms tumor identified and measured by gene expression profiles [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]
  • Identification of genes that as a whole provide strong prediction of outcomes of interest [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]
    Supervised methods such as CART or Shrunken Centroid Classifier will be used.
  • New molecular categories of Wilms tumor identified and measured by gene expression profiles [ Designated as safety issue: No ]
  • Development of a classifying system that will predict a defined number of clinically relevant categories based on expression of an established set of genes [ Designated as safety issue: No ]
  • Confirm and test the classifying system with further gene analysis by different methodologies [ Designated as safety issue: No ]
  • Validation of the classifying system [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00897637 on ClinicalTrials.gov Archive Site
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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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

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

  • 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
Other: laboratory biomarker analysis
Correlative studies
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.
Intervention: Other: laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
Not Provided
January 2100   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
United States
 
NCT00897637
AREN03B1, NCI-2009-00415, CDR0000349184, COG-AREN03B1, U10CA098543
No
Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Elizabeth Perlman, MD Children's Oncology Group
Children's Oncology Group
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP