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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00088803
First Posted: August 5, 2004
Last Update Posted: May 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
  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
  • Inheritance pattern of the A133S polymorphism in the parents of children who carry this polymorphism

Secondary Outcome Measures:
  • 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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


  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 ( Other Identifier: Children's Oncology Group )
UTSMC-0390080
CDR0000366933 ( Other Identifier: Clinical Trials.gov )
NCI-2009-00417 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: August 4, 2004
First Posted: August 5, 2004
Last Update Posted: May 19, 2016
Last Verified: May 2016

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