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Studying Biomarkers in Samples From Younger Patients With Wilms Tumor

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ClinicalTrials.gov Identifier: NCT01576198
Recruitment Status : Completed
First Posted : April 12, 2012
Last Update Posted : July 14, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:

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 or disease Intervention/treatment
Kidney Cancer Genetic: DNA analysis Genetic: nucleic acid amplification Other: diagnostic laboratory biomarker analysis Other: medical chart review

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.

Study Type : Observational
Estimated Enrollment : 2227 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Validation of Copy Number Changes by MLPA as Predictors of Relapse in Wilms Tumor
Study Start Date : April 2012
Primary Completion Date : July 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Validation of copy number changes (gain of 1q and 15q, and loss of 1p, 16q, 17p, and 22q) in FHWT by the MLPA assay

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients With Wilms Tumor


  • DNA samples from FHWT patients registered on:

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


  • 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 ClinicalTrials.gov identifier (NCT number): NCT01576198

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Elizabeth J. Perlman, MD Ann & Robert H Lurie Children's Hospital of Chicago

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01576198     History of Changes
Other Study ID Numbers: AREN11B3
COG-AREN11B3 ( Other Identifier: Children's Oncology Group )
NCI-2012-00725 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
AREN11B3 ( Other Identifier: Children's Oncology Group )
First Posted: April 12, 2012    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016

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

Additional relevant MeSH terms:
Kidney Neoplasms
Wilms Tumor
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn