Studying Biomarkers in Urine Samples From Younger Patients With Wilms Tumor

Recurrent Wilms Tumor and Other Childhood Kidney Tumors Clinical Trial

Official title:

Observational - Characterization of Urinary Metabolite Profiles in Wilms Tumor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01614808
• Other study ID #: AREN12B7
• Secondary ID: NCI-2012-01973
• Status: Completed
• Phase: N/A
• First received: June 6, 2012
• Last updated: May 6, 2015
• Start date: June 2012
• Est. completion date: June 2012

Study information

• Verified date: May 2015
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Kidney Neoplasms
• Neoplasms
• Recurrent Wilms Tumor and Other Childhood Kidney Tumors
• Stage III Wilms Tumor
• Wilms Tumor

Intervention

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Children's Oncology Group	Monrovia	California

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No