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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00088803
First received: August 4, 2004
Last updated: May 17, 2016
Last verified: May 2016
  Purpose

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 Intervention
Kidney Cancer
Genetic: molecular genetic technique
Genetic: polymerase chain reaction
Genetic: polymorphism analysis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Incidence, Inheritance, and Prognostic Significance of Polymorphisms in the RASSF1A Gene in Children With Wilms Tumors

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 471
Study Start Date: August 2004
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Diagnosis of Wilms' tumor or control participants matched for race, sex, and age.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00088803

  Show 232 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Gail E. Tomlinson, MD, PhD Simmons Cancer Center
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00088803     History of Changes
Other Study ID Numbers: AREN04B1  COG-AREN04B1  UTSMC-0390080  CDR0000366933  NCI-2009-00417 
Study First Received: August 4, 2004
Last Updated: May 17, 2016
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
recurrent Wilms tumor and other childhood kidney tumors
stage I Wilms tumor
stage II Wilms tumor
stage III Wilms tumor
stage IV Wilms tumor
stage V Wilms tumor

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Wilms Tumor
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Complex and Mixed
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on July 28, 2016