Observational - Characterization of Urinary Metabolite Profiles in Wilms Tumor
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Recurrent Wilms Tumor and Other Childhood Kidney Tumors
- Sponsor
- Children's Oncology Group
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
Time Frame: Baseline