Biomarkers in Blood and Tumor Tissue Samples From Patients With Wilms Tumor

Pilot Case-Control Study of WT1 Mutations in Wilms Tumor Patients Who Develop ESRD

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

PURPOSE: This research study is studying biomarkers in blood and tumor tissue samples from patients with Wilms tumor.

Study Overview

• Status: Completed
• Conditions: Kidney Cancer; Renal Failure
• Intervention / Treatment: Other: laboratory biomarker analysis; Genetic: mutation analysis; Genetic: polymerase chain reaction

Detailed Description

OBJECTIVES:

• To determine whether Wilms Tumor (WT) patients without WT1-associated congenital anomalies or syndromes, but with end-stage renal disease (ESRD) unrelated to progressive bilateral tumors, carry germline WT1 mutations.
• To determine whether non-syndromic WT1 germline mutation carriers have a substantially higher incidence of ESRD than do WT patients who do not harbor WT1 mutations.

OUTLINE: Archived blood and tumor tissue specimens (or DNA isolated from these samples) are analyzed for WT1 mutations by gene sequencing and PCR.

• Study Type: Observational
• Enrollment (Anticipated): 20

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Diagnosis of Wilms Tumor

Description

DISEASE CHARACTERISTICS:

• Diagnosis of Wilms Tumor (WT)

• Patients who participated in the NWTS-5 protocol

  • Non-syndromic patients who developed end-stage renal disease (ESRD) during 5-10 years for reasons other than progressive bilateral WT
  • Matched control patients who had not developed ESRD by the time (since WT onset) of ESRD diagnosis
• Blood and tumor tissue samples available

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• Not specified

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Higher incidence of ESRD in non-syndromic WT patients with germline WT1 mutations than WT patients without WT1 mutations

Collaborators and Investigators

• Sponsor: Children's Oncology Group
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Vicki Huff, PhD, M.D. Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): May 1, 2016
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: March 11, 2011
• First Submitted That Met QC Criteria: March 11, 2011
• First Posted (Estimate): March 14, 2011

Study Record Updates

• Last Update Posted (Estimate): May 18, 2016
• Last Update Submitted That Met QC Criteria: May 17, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: renal failure; stage III Wilms tumor; stage IV Wilms tumor; stage V Wilms tumor; stage I Wilms tumor; stage II Wilms tumor
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Genetic Diseases, Inborn; Neoplastic Syndromes, Hereditary; Neoplasms, Complex and Mixed; Kidney Neoplasms; Renal Insufficiency; Wilms Tumor
• Other Study ID Numbers: AREN11B1 (Other Identifier: Children's Oncology Group); COG-AREN11B1 (Other Identifier: Children's Oncology Group); NCI-2011-02850 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No