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NCT01550393 Clinical Trial

Biomarkers in Urine Samples From Patients With Wilms Tumor

Kidney Cancer Clinical Trial

Official title:
Discovery and Validation of Wilms Tumor Markers Using Urine Proteomics

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01550393
Other study ID # AREN12B4
Secondary ID COG-AREN12B4CDR0
Status Completed
Phase N/A
First received March 6, 2012
Last updated July 7, 2016
Start date March 2012

Study information
Verified date July 2016
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

RATIONALE: Studying samples of urine from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer.

PURPOSE: This clinical trial studies biomarkers in urine from patients with Wilms tumor.

Description:

OBJECTIVES:

- To validate the prognostic performance of specific-candidate Wilms tumor markers by measuring their urinary concentration using enzyme-linked immunosorbent assays (ELISAs) in urine specimens collected at diagnosis from 50 patients with favorable histology Wilms tumor who relapsed and 50 patients who did not relapse.

OUTLINE: Urine specimens are analyzed using enzyme-linked immunosorbent assays (ELISAs) for biomarkers.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group N/A to 120 Years
Eligibility DISEASE CHARACTERISTICS:

- Urine specimens collected at diagnosis will be selected from patients with stage II-III Wilms tumors, with both local and non-local sites of disease relapse

- Clinical patient information (urinalysis/macro, age, gender, congenital defects/syndromes, comorbidities, tumor stage, size, pathology, therapy, outcome) available

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- Not specified

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Genetic:
• proteomic profiling

Other:
• enzyme-linked immunosorbent assay

• laboratory biomarker analysis

• medical chart review

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Wilms tumor biomarkers identified by ELISA No
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