Studying Biomarkers in Urine Samples From Younger Patients With Wilms Tumor

Completed

• Conditions: Stage III Wilms Tumor; Recurrent Wilms Tumor and Other Childhood Kidney Tumors
• Interventions: Other: laboratory biomarker analysis

• Registration Number: NCT01614808
• Lead Sponsor: Children's Oncology Group

Brief Summary

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

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 Timeline

• Study Start: 2012-06
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Study First Submitted: 2012-06-06
• Study First Submitted QC: 2012-06-06
• Study First Posted: 2012-06-08
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-06
• Last Update Posted: 2015-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	laboratory biomarker analysis	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Children's Oncology Group; 🇺🇸 Monrovia, California, United States