Studying Biomarkers in Samples From Younger 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: April 11, 2012
Last updated: April 21, 2012
Last verified: April 2012

RATIONALE: Studying samples of blood, tissue, or bone marrow from patients with cancer in the laboratory may help doctors to 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: DNA analysis
Genetic: nucleic acid amplification
Other: diagnostic laboratory biomarker analysis
Other: medical chart review

Study Type: Observational
Official Title: Validation of Copy Number Changes by MLPA as Predictors of Relapse in Wilms Tumor

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Validation of copy number changes (gain of 1q and 15q, and loss of 1p, 16q, 17p, and 22q) in FHWT by the MLPA assay [ Designated as safety issue: No ]

Estimated Enrollment: 2227
Study Start Date: April 2012
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Detailed Description:


  • To analyze 250 favorable-histology Wilms tumor (FHWT) samples from patients registered on NWTS4 for gain of 1q and 15q, and loss of 1p, 16q, 17p, and 22q by subtelomeric multiplex ligation-dependent probe amplification (MLPA), and to determine their association with relapse-free and overall survival.
  • To develop a robust multiplex MLPA test using multiple synthesized probes to those targets identified as significantly associated with relapse in Aim 1.
  • To validate the multiplex MLPA test designed and tested in Aim 2 on an independent set of 1727 FHWT and 250 anaplastic WT registered on NWTS-5.

OUTLINE: Archived DNA samples are analyzed for gain of 1q and 15q, and loss of 1p, 16q, 17p, and 22q by MLPA. Assay results are then researched for accuracy, clinical validity, sensitivity, precision, and potential analytical interferences.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • DNA samples from FHWT patients registered on:

    • NWTS-4
    • NWTS-5 with focal and diffuse anaplasia tumors


  • Not specified


  • Not specified
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Please refer to this study by its identifier: NCT01576198

Sponsors and Collaborators
Children's Oncology Group
Principal Investigator: Elizabeth J. Perlman, MD Ann & Robert H Lurie Children's Hospital of Chicago
  More Information

Additional Information:
No publications provided

Responsible Party: Peter C. Adamson, Children's Oncology Group - Group Chair Office Identifier: NCT01576198     History of Changes
Other Study ID Numbers: CDR0000730403, COG-AREN11B3
Study First Received: April 11, 2012
Last Updated: April 21, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
Wilms tumor and other childhood kidney tumors processed this record on March 25, 2015