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

NCT ID: NCT00503893

Last Updated: 2020-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

295 participants

Study Classification

OBSERVATIONAL

Study Start Date

1980-12-01

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Wilms' Tumor Aniridia

Study Design

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Observational Model Type

FAMILY_BASED

Study Time Perspective

PROSPECTIVE

Study Groups

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Wilm's Tumor PO1

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

Questionnaire

Intervention Type BEHAVIORAL

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

Blood specimen

Intervention Type OTHER

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

Interventions

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Questionnaire

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

Intervention Type BEHAVIORAL

Blood specimen

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

Intervention Type OTHER

Other Intervention Names

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Survey

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1\. Patients who do not meet inclusion eligibility criteria are excluded.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Louise C. Strong, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

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P01CA034936-23

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P80-099

Identifier Type: -

Identifier Source: org_study_id

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