Studying Biomarkers in Samples From Younger Patients With Wilms Tumor

Biological Analysis of Ethnic Variations in Wilms Tumor

RATIONALE: Studying samples of tissue and urine from patients with cancer in the laboratory may help doctor learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies biomarkers in samples from younger patients with Wilms tumor.

Study Overview

• Status: Completed
• Conditions: Kidney Cancer
• Intervention / Treatment: Genetic: gene expression analysis; Other: laboratory biomarker analysis; Genetic: proteomic profiling; Genetic: reverse transcriptase-polymerase chain reaction; Other: immunohistochemistry staining method; Genetic: western blotting; Procedure: spectroscopy

Detailed Description

OBJECTIVES:

• To determine a unique molecular "finger print" of primary Wilms tumor arising in ethnically diverse children who are at increased risk to develop this lethal malignancy and subsequently relapse.
• To determine a unique protein "finger print" from the urine of ethnically diverse children who develop Wilms tumor and subsequent relapse.

OUTLINE: Formalin-fixed paraffin-embedded and snap-frozen primary tissue samples, and urine samples collected at the time of diagnosis and before treatment, are analyzed for molecular and protein profile by MALDI-TOF mass spectroscopy, western blotting, immunohistochemistry, and reverse-transcriptase polymerase chain reaction (RT-PCR) assays.

• Study Type: Observational
• Enrollment (Anticipated): 20

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Diagnosed with Wilms tumor

Description

DISEASE CHARACTERISTICS:

• Diagnosed with Wilms tumor
• Specimens from African-American and from Caucasian children
• Specimens from each ethnicity who relapsed
• Specimens from each ethnicity who did NOT relapse

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• Not specified

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Molecular "finger print" of primary Wilms tumor in ethnically diverse children
Protein "finger print" from the urine of ethnically diverse children

Collaborators and Investigators

• Sponsor: Children's Oncology Group
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Harold N. Lovvorn, III, MD, Vanderbilt Children's Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: February 22, 2012
• First Submitted That Met QC Criteria: February 25, 2012
• First Posted (Estimate): March 2, 2012

Study Record Updates

• Last Update Posted (Estimate): May 18, 2016
• Last Update Submitted That Met QC Criteria: May 17, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: stage III Wilms tumor; stage IV Wilms tumor; stage V Wilms tumor; stage I Wilms tumor; stage II Wilms tumor; recurrent Wilms tumor and other childhood kidney tumors
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Genetic Diseases, Inborn; Neoplastic Syndromes, Hereditary; Neoplasms, Complex and Mixed; Kidney Neoplasms; Wilms Tumor
• Other Study ID Numbers: AREN12B2 (Other Identifier: Children's Oncology Group); COG-AREN12B2 (Other Identifier: Children's Oncology Group); CDR0000726713 (Other Identifier: Clinical trials.gov); NCI-2012-00686 (Registry Identifier: CTRP (Clinical Trial Reporting Program))