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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01314391

Enrollment

Registered

2011-03-14

Start date

2011-08-31

Completion date

Unknown

Last updated

2016-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Cancer, Renal Failure

Keywords

stage I Wilms tumor, stage II Wilms tumor, stage III Wilms tumor, stage IV Wilms tumor, stage V Wilms tumor, renal failure

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.

Interventions

GENETICmutation analysis

GENETICpolymerase chain reaction

OTHERlaboratory biomarker analysis

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 15 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026