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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2004 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00088803
First received: August 4, 2004
Last updated: June 11, 2009
Last verified: November 2004

August 4, 2004
June 11, 2009
August 2004
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  • Presence of the A133S polymorphism of the RASSF1A tumor suppressor gene in germline DNAs of children with Wilms' tumor [ Designated as safety issue: No ]
  • Inheritance pattern of the A133S polymorphism in the parents of children who carry this polymorphism [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00088803 on ClinicalTrials.gov Archive Site
  • Differences in age at diagnosis, stage, histology, site of primary tumor, and outcome between patients with vs without the A133S polymorphism [ Designated as safety issue: No ]
  • Whether the S131F RASSF1A variant is a true polymorphism [ Designated as safety issue: No ]
  • Polymorphic differences in this gene based on ethnicity and sex [ Designated as safety issue: No ]
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DNA Variations in the Gene in Young Patients With Wilms' Tumor
The Incidence, Inheritance, and Prognostic Significance of Polymorphisms in the RASSF1A Gene in Children With Wilms Tumors

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.

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.

Observational
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Kidney Cancer
  • Genetic: molecular genetic technique
  • Genetic: polymerase chain reaction
  • Genetic: polymorphism analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
471
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DISEASE CHARACTERISTICS:

  • Diagnosis of Wilms' tumor OR
  • Control participants matched for race, sex, and age

    • No prior or concurrent history of cancer OR
  • Parents of children involved in the study

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
Both
up to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands,   United States,   Canada,   Australia,   Puerto Rico,   New Zealand,   Switzerland
 
NCT00088803
CDR0000366933, COG-AREN04B1, UTSMC-0390080
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Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: Gail E. Tomlinson, MD, PhD Simmons Cancer Center
National Cancer Institute (NCI)
November 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP