Gene Expression Profiles to Categorize Wilms Tumors

NCT00897637 | Completed

• 5 other identifiers: AREN03B1NCI-2009-00415CDR0000349184COG-AREN03B1U10CA098543
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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

Interventions

laboratory biomarker analysis OTHER

Correlative studies

Observational

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Children's Oncology Group

Arcadia, California, 91006-3776, United States

Location

Saint Mary's Hospital

West Palm Beach, Florida, 33407, United States

Location

MeSH Terms

Conditions

Wilms Tumor

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Elizabeth Perlman, MD

  Children's Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: February 1, 2004
• Primary Completion: May 1, 2016
• Last Updated: May 19, 2016

Record last verified: 2016-05

Locations

US (2)