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:

National Cancer Institute (NCI)

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

History of Changes

Tracking Information

First Received Date ^ICMJE

August 4, 2004

Last Updated Date

June 11, 2009

Start Date ^ICMJE

August 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00088803 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

The Incidence, Inheritance, and Prognostic Significance of Polymorphisms in the RASSF1A Gene in Children With Wilms Tumors

Brief Summary

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.

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Not Provided

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

Kidney Cancer

Intervention ^ICMJE

Genetic: molecular genetic technique
Genetic: polymerase chain reaction
Genetic: polymorphism analysis

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

471

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 18 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Canada, Netherlands, New Zealand, Puerto Rico, Switzerland

Administrative Information

NCT Number ^ICMJE

NCT00088803

Other Study ID Numbers ^ICMJE

CDR0000366933, COG-AREN04B1, UTSMC-0390080

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Children's Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Gail E. Tomlinson, MD, PhD

Simmons Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

November 2004

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

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