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
  Purpose

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.


Condition Intervention
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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Categorization of Wilms Tumors by Genetic Expression

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 600
Study Start Date: February 2004
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other: laboratory biomarker analysis
Correlative studies

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00897637

Locations
United States, California
Children's Oncology Group Recruiting
Arcadia, California, United States, 91006-3776
Contact: Elizabeth J. Perlman, MD    773-880-4306    eperlman@childrensmemorial.org   
Principal Investigator: Elizabeth J. Perlman, MD         
United States, Florida
Saint Mary's Hospital Recruiting
West Palm Beach, Florida, United States, 33407
Contact: Narayana Gowda, MD    561-844-6363      
Principal Investigator: Narayana Gowda, MD         
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Elizabeth Perlman, MD Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00897637     History of Changes
Other Study ID Numbers: AREN03B1, NCI-2009-00415, CDR0000349184, COG-AREN03B1, U10CA098543
Study First Received: May 9, 2009
Last Updated: February 19, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Wilms Tumor
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on July 10, 2014