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
Recruitment status was Active, not recruiting
Sponsor:
Children's Oncology Group
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
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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 |
| 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 National Cancer Institute (NCI):
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 |
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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00088803
Show 232 Study Locations
Show 232 Study LocationsSponsors and Collaborators
Children's Oncology Group
Investigators
| Study Chair: | Gail E. Tomlinson, MD, PhD | Simmons Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00088803 History of Changes |
| Other Study ID Numbers: | CDR0000366933, COG-AREN04B1, UTSMC-0390080 |
| Study First Received: | August 4, 2004 |
| Last Updated: | June 11, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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:
|
Carcinoma, Renal Cell Kidney Neoplasms Wilms Tumor Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Neoplasms, Complex and Mixed Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn |
ClinicalTrials.gov processed this record on June 17, 2013