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

Kidney Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01314391
• Other study ID #: AREN11B1
• Secondary ID: COG-AREN11B1NCI-
• Status: Completed
• Phase: N/A
• First received: March 11, 2011
• Last updated: May 17, 2016
• Start date: August 2011

Study information

• Verified date: May 2016
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 15 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Kidney Cancer
• Renal Failure
• Renal Insufficiency
• Wilms Tumor

Intervention

Genetic:
• mutation analysis

• polymerase chain reaction

Other:
• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Higher incidence of ESRD in non-syndromic WT patients with germline WT1 mutations than WT patients without WT1 mutations			No

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database