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Studying Biomarkers in Samples From Younger Patients With Wilms Tumor

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group Identifier:
First received: February 22, 2012
Last updated: May 17, 2016
Last verified: May 2016

RATIONALE: Studying samples of tissue and urine from patients with cancer in the laboratory may help doctor learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies biomarkers in samples from younger patients with Wilms tumor.

Condition Intervention
Kidney Cancer Genetic: gene expression analysis Genetic: proteomic profiling Genetic: reverse transcriptase-polymerase chain reaction Genetic: western blotting Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: spectroscopy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Biological Analysis of Ethnic Variations in Wilms Tumor

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Molecular "finger print" of primary Wilms tumor in ethnically diverse children
  • Protein "finger print" from the urine of ethnically diverse children

Estimated Enrollment: 20
Study Start Date: February 2012
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Detailed Description:


  • To determine a unique molecular "finger print" of primary Wilms tumor arising in ethnically diverse children who are at increased risk to develop this lethal malignancy and subsequently relapse.
  • To determine a unique protein "finger print" from the urine of ethnically diverse children who develop Wilms tumor and subsequent relapse.

OUTLINE: Formalin-fixed paraffin-embedded and snap-frozen primary tissue samples, and urine samples collected at the time of diagnosis and before treatment, are analyzed for molecular and protein profile by MALDI-TOF mass spectroscopy, western blotting, immunohistochemistry, and reverse-transcriptase polymerase chain reaction (RT-PCR) assays.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diagnosed with Wilms tumor


  • Diagnosed with Wilms tumor
  • Specimens from African-American and from Caucasian children
  • Specimens from each ethnicity who relapsed
  • Specimens from each ethnicity who did NOT relapse


  • 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: NCT01542333

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Harold N. Lovvorn, III, MD Vanderbilt Children's Hospital
  More Information

Responsible Party: Children's Oncology Group Identifier: NCT01542333     History of Changes
Other Study ID Numbers: AREN12B2
COG-AREN12B2 ( Other Identifier: Children's Oncology Group )
CDR0000726713 ( Other Identifier: Clinical )
AREN12B2 ( Other Identifier: Children's Oncology Group )
NCI-2012-00686 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Study First Received: February 22, 2012
Last Updated: May 17, 2016

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

Additional relevant MeSH terms:
Wilms Tumor
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Complex and Mixed
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn processed this record on July 27, 2017