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Biomarkers in Urine Samples From Patients With Wilms Tumor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01550393
Recruitment Status : Completed
First Posted : March 12, 2012
Last Update Posted : July 11, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief 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.

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

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Discovery and Validation of Wilms Tumor Markers Using Urine Proteomics
Study Start Date : March 2012
Actual Primary Completion Date : July 2016

Primary Outcome Measures :
  1. Wilms tumor biomarkers identified by ELISA

Biospecimen Retention:   Samples With DNA

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01550393

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
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Principal Investigator: Elizabeth A. Mullen, MD Dana-Farber Cancer Institute
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Responsible Party: Children's Oncology Group Identifier: NCT01550393    
Other Study ID Numbers: AREN12B4
COG-AREN12B4 ( Other Identifier: Children's Oncology Group )
CDR0000727337 ( Other Identifier: Clinical )
AREN12B4 ( Other Identifier: Children's Oncology Group )
NCI-2012-00702 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: March 12, 2012    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016
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:
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Kidney Neoplasms
Wilms Tumor
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms by Histologic Type
Neoplasms, Complex and Mixed
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn