Trials / Completed
CompletedNCT01614808
Studying Biomarkers in Urine Samples From Younger Patients With Wilms Tumor
Observational - Characterization of Urinary Metabolite Profiles in Wilms Tumor
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 90 (actual)
- Sponsor
- Children's Oncology Group · Network
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | laboratory biomarker analysis | Correlative studies |
Timeline
- Start date
- 2012-06-01
- Primary completion
- 2012-06-01
- Completion
- 2012-06-01
- First posted
- 2012-06-08
- Last updated
- 2015-05-07
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01614808. Inclusion in this directory is not an endorsement.