Studying Biomarkers in Urine Samples From Younger Patients With Wilms Tumor

Observational - Characterization of Urinary Metabolite Profiles in Wilms Tumor

This research study is looking at biomarkers in urine samples from patients with Wilms tumor. Studying samples of urine from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment

Study Overview

• Status: Completed
• Conditions: Recurrent Wilms Tumor and Other Childhood Kidney Tumors; Stage III Wilms Tumor
• Intervention / Treatment: Other: laboratory biomarker analysis

Detailed Description

PRIMARY OBJECTIVES:

I. To characterize the urinary metabolite signature of 10 stage III, favorable-histology, Wilms tumor patients from the Cooperative Human Tissue Network (CHTN) Databank, as distinct from 10 normal controls.

II. To characterize and compare the urinary metabolite profile in 50 randomly selected, stage III, favorable-histology, Wilms tumor patients enriched with an additional 30 stage III Wilms tumor patients who have relapsed.

III. To establish if the potential poor outcome (defined as relapse) in the favorable-histology group has a specific metabolite signature.

IV. To characterize the urinary metabolite signature of Wilms tumor in patients with unfavorable histology (diffuse anaplasia) and compare it to those with favorable histology.

OUTLINE:

Archived urine samples are analyzed for specific metabolite patterns by nuclear magnetic resonance (NMR) spectroscopy and principal component analysis (PCA). Tumor tissue may also be examined by NMR and PCA.

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• United States
  • California
    • Monrovia, California, United States, 91006-3776
      • Children's Oncology Group

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

Patients diagnosed with stage III, favorable-histology Wilms tumors and patients diagnosed with stage III, favorable-histology Wilms tumors who have relapsed.

Description

Inclusion Criteria:

• Patients diagnosed with stage III, favorable-histology Wilms tumors and patients diagnosed with stage III, favorable-histology Wilms tumors who have relapsed

  • Tumor samples available from both groups
• Urine samples from the CHTN bank
• Control urine samples
• Urine samples from patients with unfavorable histology
• Not specified
• Not specified

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational; Archived urine samples are analyzed for specific metabolite patterns by nuclear magnetic resonance (NMR) spectroscopy and principal component analysis (PCA). Tumor tissue may also be examined by NMR and PCA.	Other: laboratory biomarker analysis; Correlative studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Identification of metabolomic markers in urine that would assist in identifying higher risk of relapse of Wilms tumor in otherwise lower-risk stratified patients as assessed by NMR spectroscopy and PCA	Baseline

Collaborators and Investigators

• Sponsor: Children's Oncology Group
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Dawn Maclellan, MD, Children's Oncology Group

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: June 6, 2012
• First Submitted That Met QC Criteria: June 6, 2012
• First Posted (Estimate): June 8, 2012

Study Record Updates

• Last Update Posted (Estimate): May 7, 2015
• Last Update Submitted That Met QC Criteria: May 6, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Genetic Diseases, Inborn; Neoplastic Syndromes, Hereditary; Neoplasms, Complex and Mixed; Neoplasms; Kidney Neoplasms; Wilms Tumor
• Other Study ID Numbers: AREN12B7; NCI-2012-01973 (Registry Identifier: CTRP (Clinical Trial Reporting Program))