DNA Variations in the Gene in Young Patients With Wilms' Tumor

Completed

• Conditions: Kidney Cancer

• Registration Number: NCT00088803
• Lead Sponsor: Children's Oncology Group

Brief Summary

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

PURPOSE: This laboratory study is looking at DNA variations in the RASSF1A gene in young patients with Wilms' tumor.

Detailed Description

OBJECTIVES:

Primary

* Determine the presence of the A133S polymorphism in the RASSF1A tumor suppressor gene by screening germline DNAs of children with Wilms' tumor.

* Determine the inheritance pattern of the A133S polymorphism by evaluating the parents of children who carry this polymorphism.

Secondary

* Determine the differences in age at diagnosis, stage, histology, site of primary tumor, and outcome, between patients with vs without the A133S polymorphism.

* Determine whether the S131F RASSF1A variant is a true polymorphism in these patients.

* Determine the polymorphic differences in this gene between these patients based on ethnicity and sex.

OUTLINE: This is a multicenter study. Patients are stratified according to age at diagnosis, stage, histology, site of primary tumor, and outcome.

Genomic DNA samples are purified from peripheral blood of patients and controls and analyzed by polymerase chain reaction for the RASSF1A gene. DNA is also analyzed from parents of patients with the A133S polymorphism.

PROJECTED ACCRUAL: A total of 471 participants (229 Wilms' tumor patients and 200 control participants plus 42 parents) will be accrued for this study.

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2004-08-04
• Study First Submitted QC: 2004-08-04
• Study First Posted: 2004-08-05
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Last Update Submitted: 2016-05-17
• Last Update Posted: 2016-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 471

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of the A133S polymorphism of the RASSF1A tumor suppressor gene in germline DNAs of children with Wilms' tumor
Inheritance pattern of the A133S polymorphism in the parents of children who carry this polymorphism

Secondary Outcome Measures

Name	Time	Method
Differences in age at diagnosis, stage, histology, site of primary tumor, and outcome between patients with vs without the A133S polymorphism
Whether the S131F RASSF1A variant is a true polymorphism
Polymorphic differences in this gene based on ethnicity and sex

Trial Locations

Locations (232)

University of Alabama at Birmingham Comprehensive Cancer Center; 🇺🇸 Birmingham, Alabama, United States

University of South Alabama Cancer Research Institute; 🇺🇸 Mobile, Alabama, United States

Phoenix Children's Hospital; 🇺🇸 Phoenix, Arizona, United States

Arizona Cancer Center at University of Arizona Health Sciences Center; 🇺🇸 Tucson, Arizona, United States

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Southern California Permanente Medical Group; 🇺🇸 Downey, California, United States

Rebecca and John Moores UCSD Cancer Center; 🇺🇸 La Jolla, California, United States

Loma Linda University Cancer Institute at Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States

Jonathan Jaques Children's Cancer Center at Miller Children's Hospital; 🇺🇸 Long Beach, California, United States

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States

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