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

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.

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Key information

Conditions

Kidney Cancer Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Complex and Mixed Neoplastic Syndromes, Hereditary Renal Failure Renal Insufficiency Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Wilms Tumor

Age range

Up to 15 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mutation analysis

Genetic

polymerase chain reaction

Genetic

laboratory biomarker analysis

Other

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2016
First posted: Mar 14, 2011
Registry last updated: May 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed