Biomarkers in Tumor Tissue Samples From Young Patients With Very Low Risk Wilms Tumors

NCT01004783 | Completed

• 4 other identifiers: AREN10B1COG-AREN10B1CDR0000657973NCI-2011-02199
• Study Type: observational
• Target: 165
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This clinical trial studies biomarkers in tumor tissue samples from young patients with very low risk Wilms tumors.

Conditions

Kidney Cancer

Keywords

stage I Wilms tumor; stage II Wilms tumor; epithelial predominant Wilms tumor

Outcome Measures

Primary Outcomes (4)

• Utility of CUGBP2, HMGA2, and MEIS2 mRNA expression and 11p15 methylation to define a population of pediatric patients with very low risk Wilms tumor (VLRWT) that have virtually no risk of relapse

• Utility of WT-1 mutation and 11p15 loss of heterozygosity analysis to determine a population of VLRWT that have a higher risk of relapse when not treated with chemotherapy

• Utility of NFYA, STRA6, TOB2, PDCD4, and SP3 mRNA expression to predict relapse in VLRWT

• Feasibility of broadening the definition of VLRWT through analysis of stage I and II epithelial differentiated tumors registered on clinical trial COG-Q9401 (NWTS-5) for CUGBP2, HMGA2, MEIS2, and 11p15 methylation

Interventions

DNA methylation analysis GENETIC

gene expression analysis GENETIC

loss of heterozygosity analysis GENETIC

microarray analysis GENETIC

mutation analysis GENETIC

polymerase chain reaction GENETIC

reverse transcriptase-polymerase chain reaction GENETIC

laboratory biomarker analysis OTHER

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with very low risk Wilms tumor registered on clinical trial COG-AREN03B2 or patients with stage I or II epithelial tubular differentiated Wilms tumor registered on clinical trial COG-Q9401 (NWTS-5)

DISEASE CHARACTERISTICS: * Meets 1 of the following criteria: * Patient with very low risk Wilms tumor registered on clinical trial COG-AREN03B2 * Patient with stage I or II epithelial tubular differentiated Wilms tumor registered on clinical trial COG-Q9401 (NWTS-5) PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not Specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

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

Biospecimen

Retention: SAMPLES WITH DNA

Tumor Tissue

MeSH Terms

Conditions

Kidney Neoplasms; Wilms Tumor

Interventions

DNA Methylation; Gene Expression Profiling; Microarray Analysis; Polymerase Chain Reaction; Reverse Transcriptase Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Methylation; Alkylation; Biochemical Phenomena; Chemical Phenomena; Metabolism; Genetic Phenomena; Genetic Techniques; Investigative Techniques; Microchip Analytical Procedures; Nucleic Acid Amplification Techniques

Study Officials

• Elizabeth J. Perlman, MD

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 29, 2009
• First Posted: October 30, 2009
• Study Start: October 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: May 7, 2015

Record last verified: 2015-05