Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Biomarkers in Urine Samples From Patients With Wilms Tumor

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: March 6, 2012
Last updated: April 25, 2012
Last verified: April 2012

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

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

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

Estimated Enrollment: 100
Study Start Date: March 2012
Estimated Primary Completion Date: April 2012 (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.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01550393

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

Additional Information:
No publications provided

Responsible Party: Peter C. Adamson, Children's Oncology Group - Group Chair Office Identifier: NCT01550393     History of Changes
Other Study ID Numbers: CDR0000727337, COG-AREN12B4
Study First Received: March 6, 2012
Last Updated: April 25, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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 February 27, 2015