Studying Biomarkers in Urine Samples From Younger Patients With Wilms Tumor

Observational - Characterization of Urinary Metabolite Profiles in Wilms Tumor

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01614808

Enrollment

Registered

2012-06-08

Start date

2012-06-30

Completion date

2012-06-30

Last updated

2015-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Wilms Tumor and Other Childhood Kidney Tumors, Stage III Wilms Tumor

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.

Interventions

OTHERlaboratory biomarker analysis

Correlative studies

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026