Biomarkers in Urine Samples From Patients With Wilms Tumor

This study is ongoing, but not recruiting participants.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group Identifier:
First received: March 6, 2012
Last updated: September 30, 2015
Last verified: May 2015

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.

Condition Intervention
Kidney Cancer
Genetic: proteomic profiling
Other: enzyme-linked immunosorbent assay
Other: laboratory biomarker analysis
Other: medical chart review

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Discovery and Validation of Wilms Tumor Markers Using Urine Proteomics

Resource links provided by NLM:

Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Wilms tumor biomarkers identified by ELISA [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA


Estimated Enrollment: 100
Study Start Date: March 2012
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   up to 120 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with stage II-III Wilms tumors



  • 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


  • Not specified


  • Not specified
  Contacts and Locations
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Please refer to this study by its identifier: NCT01550393

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Elizabeth A. Mullen, MD Dana-Farber Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Children's Oncology Group Identifier: NCT01550393     History of Changes
Other Study ID Numbers: AREN12B4, COG-AREN12B4, CDR0000727337, AREN12B4, NCI-2012-00702
Study First Received: March 6, 2012
Last Updated: September 30, 2015
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
stage II Wilms tumor
stage III Wilms tumor
recurrent Wilms tumor and other childhood kidney tumors

Additional relevant MeSH terms:
Wilms Tumor
Genetic Diseases, Inborn
Kidney Diseases
Kidney Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Complex and Mixed
Neoplastic Syndromes, Hereditary
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms processed this record on October 09, 2015