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

Completed

• Conditions: Renal Failure; Kidney Cancer

• Registration Number: NCT01314391
• Lead Sponsor: Children's Oncology Group

Brief Summary

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.

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 Timeline

• Study First Submitted: 2011-03-11
• Study First Submitted QC: 2011-03-11
• Study First Posted: 2011-03-14
• Study Start: 2011-08
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Last Update Submitted: 2016-05-17
• Last Update Posted: 2016-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Higher incidence of ESRD in non-syndromic WT patients with germline WT1 mutations than WT patients without WT1 mutations