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Clinical Trials/NCT00088803
NCT00088803
Completed
Not Applicable

The Incidence, Inheritance, and Prognostic Significance of Polymorphisms in the RASSF1A Gene in Children With Wilms Tumors

Children's Oncology Group232 sites in 1 country471 target enrollmentAugust 2004
ConditionsKidney Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Kidney Cancer
Sponsor
Children's Oncology Group
Enrollment
471
Locations
232
Primary Endpoint
Presence of the A133S polymorphism of the RASSF1A tumor suppressor gene in germline DNAs of children with Wilms' tumor
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2004
End Date
May 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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 Outcomes

  • 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

Study Sites (232)

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