Genetics of Wilms' Tumor and/or the Associated Conditions of Aniridia, Hemihypertrophy, and Genitourinary Anomalies

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT00503893

Collaborator

National Cancer Institute (NCI) (NIH)

295

Enrollment

Location

480

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this clinical research study is to collect information and blood samples to try to learn why some people develop cancers and tumors, why some families have more cancers than others, and whether certain genes or regions of DNA (the genetic material of cells) affect a person's risk of getting cancer.

This is an investigational study.

Up to 1500 patients and family members will take part in this study. All will be enrolled at MD Anderson.

Condition or Disease	Intervention/Treatment	Phase
Wilms' Tumor Aniridia	Behavioral: Questionnaire Other: Blood specimen

Detailed Description

If you choose to take part in this study, blood (about 10 teaspoons) will be drawn for genetic testing. The blood may be drawn more than 1 time, depending on how much blood is drawn at the first visit, and if you are available for more blood draws. If this is the case, your doctor will discuss any extra blood draws with you.

For small children (less than 5 years old), about 2 teaspoons will be drawn. Children who are 5 years old or older will not have more than 3 teaspoons drawn.

You will complete a questionnaire about your medical history and family medical history. The questionnaire should take about 1 hour to complete. The study staff will also review your medical records.

You will be asked to allow the study staff to collect any of your tissue (whether healthy or cancerous) that is leftover from surgeries performed as part of your standard care. This may be from any past or future surgeries or any tissue being stored at MD Anderson or elsewhere. No new surgeries or biopsies will be performed for this study.

Before your information, tissue samples, and/or bodily fluids can be used for research, the people doing the research must get specific approval from the Institutional Review Board (IRB) of MD Anderson. The IRB is a committee made up of doctors, researchers, and members of the community. The IRB is responsible for protecting the participants involved in research studies and making sure all research is done in a safe and ethical manner. All research done at MD Anderson, including research involving your information, tissue samples, and/or bodily fluids, must first be approved by the IRB.

You may be contacted either by phone or mail 1 time a year, so that the study staff can update your medical history and information. If contacted by phone, this call should last about 30 minutes.

Study Design

Study Type:

Observational

Actual Enrollment :

295 participants

Observational Model:

Family-Based

Time Perspective:

Prospective

Official Title:

Genetics of Wilms' Tumor and/or the Associated Conditions of Aniridia, Hemihypertrophy, and Genitourinary Anomalies

Actual Study Start Date :

Dec 1, 1980

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Wilm's Tumor PO1 Familial and Sporadic Wilm's tumor, genitourinary anomalies, Beckwith-Wiedemann hemihypertrophy and/or aniridia.	Behavioral: Questionnaire Questionnaire regarding medical history and family medical history that will take about 1 hour to complete. Other Names: Survey Other: Blood specimen Blood (about 10 teaspoons) will be drawn from a vein for genetic testing. The blood may be drawn more than one time.

Arm

Intervention/Treatment

Wilm's Tumor PO1

Familial and Sporadic Wilm's tumor, genitourinary anomalies, Beckwith-Wiedemann hemihypertrophy and/or aniridia.

Behavioral: Questionnaire

Questionnaire regarding medical history and family medical history that will take about 1 hour to complete.

Other Names:

Survey

Other: Blood specimen

Blood (about 10 teaspoons) will be drawn from a vein for genetic testing. The blood may be drawn more than one time.

Outcome Measures

Primary Outcome Measures

Genetic Events Involved in Development of Wilms' tumor, Genitourinary Anomalies, Hemihypertrophy and Beckwith-Wiedemann, and/or Aniridia [32 Years (Descriptive data collected using questionnaires)]
Characterize genetic events by a combined molecular biology/epidemiologic approach

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients with familial and sporadic Wilm's tumor, genitourinary anomalies, Beckwith-Wiedemann hemihypertrophy and/or aniridia, and family members of patients.