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

Genetic Data

+ genetic Data

+ genetic Data

Collected from today forward - Prospective
Genetic
Who is being recruted

Urogenital Diseases+14

+ 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: May 19, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2004

Actual 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.

NCT00088803
Principal SponsorChildren's Oncology Group
Last updated: May 19, 2016
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 enrolled

Total 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.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplastic Syndromes, HereditaryUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsNeoplasms, Complex and MixedGenetic Diseases, InbornFemale Urogenital DiseasesMale Urogenital DiseasesKidney NeoplasmsWilms Tumor

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

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, United StatesOpen University of Alabama at Birmingham Comprehensive Cancer Center in Google Maps

University of South Alabama Cancer Research Institute

Mobile, United States

Phoenix Children's Hospital

Phoenix, United States

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, United States
Completed232 Study Centers