Completed

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

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Urogenital Diseases
+13

+ Female Urogenital Diseases and Pregnancy Complications
+ Kidney Diseases
Until 18 Years
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: August 2004
See protocol details

Summary

Principal SponsorChildren's Oncology Group
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 2004Actual date on which the first participant was enrolled.

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.

Official TitleThe Incidence, Inheritance, and Prognostic Significance of Polymorphisms in the RASSF1A Gene in Children With Wilms Tumors 
NCT00088803
Principal SponsorChildren's Oncology Group
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
471 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Case-Control
These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.

How participants are selected
Participants are selected without using randomization. They may be chosen based on convenience, access, or willingness to participate. This approach is common when random selection isn’t practical.
Another way to select participants is through a probability sample, where participants are chosen randomly, so everyone has an equal chance to be included.

How information is collected
Researchers start collecting data from the present day forward, following participants over time to observe outcomes. This approach helps identify how exposures or behaviors may lead to health events in the future.Other Ways to Collect Data
Retrospective: These studies use existing medical records or past data.
Cross-sectional: These studies collect data at one single point in time.
Others: Some studies use a mix of approaches or less common designs depending on the research goal.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Until 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplastic Syndromes, Hereditary
Wilms Tumor
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Neoplasms, Complex and Mixed
Genetic Diseases, Inborn
Female Urogenital Diseases
Male Urogenital Diseases
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 232 locations
Suspended
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, United StatesSee the location
Suspended
University of South Alabama Cancer Research InstituteMobile, United States
Suspended
Phoenix Children's HospitalPhoenix, United States
Suspended
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, United States
Completed232 Study Centers
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