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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-00415 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000349184 | Other Identifier | Clinical Trials.gov | |
| COG-AREN03B1 | Other Identifier | Children's Oncology Group | |
| U10CA098543 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laboratory biomarker analysis | Other | Correlative studies |
|
| Measure | Description | Time Frame |
|---|---|---|
| New molecular categories of Wilms tumor identified and measured by gene expression profiles | Up to 6 years | |
| Identification of genes that as a whole provide strong prediction of outcomes of interest | Supervised methods such as CART or Shrunken Centroid Classifier will be used. | Up to 6 years |
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Inclusion Criteria:
Specimens from patients previously enrolled as "On Study" or "Followed Biology Only" on protocol NWTSG-5 (COG-Q9401)
National Wilms Tumor Study Group/Children's Oncology Group pathology review showing "favorable" histology
Sufficient biology samples available without using biology bank reserves
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Specimens from patients previously enrolled as "On Study" or "Followed Biology Only" on protocol NWTSG-5 (COG-Q9401)
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Perlman, MD | Children's Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Oncology Group | Arcadia | California | 91006-3776 | United States | ||
| Saint Mary's Hospital |
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| ID | Term |
|---|---|
| D009396 | Wilms Tumor |
| ID | Term |
|---|---|
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
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| West Palm Beach |
| Florida |
| 33407 |
| United States |
| D014571 |
| Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009386 | Neoplastic Syndromes, Hereditary |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |