DNA Variations in the Gene in Young Patients With Wilms' Tumor
|ClinicalTrials.gov Identifier: NCT00088803|
Recruitment Status : Completed
First Posted : August 5, 2004
Last Update Posted : May 19, 2016
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.
|Condition or disease||Intervention/treatment|
|Kidney Cancer||Genetic: molecular genetic technique Genetic: polymerase chain reaction Genetic: polymorphism analysis|
- 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.
- 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 Type :||Observational|
|Estimated Enrollment :||471 participants|
|Observational Model:||Case Control|
|Official Title:||The Incidence, Inheritance, and Prognostic Significance of Polymorphisms in the RASSF1A Gene in Children With Wilms Tumors|
|Study Start Date :||August 2004|
|Actual Primary Completion Date :||May 2016|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00088803
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|Study Chair:||Gail E. Tomlinson, MD, PhD||Simmons Cancer Center|