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

Aniridia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00503893
• Other study ID #: P80-099
• Secondary ID: P01CA034936-23
• Status: Active, not recruiting
• Start date: December 1, 1980
• Est. completion date: December 2020

Study information

• Verified date: January 2020
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 295
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Aniridia
• Congenital Abnormalities
• Wilms Tumor
• Wilms' Tumor

Intervention

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

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.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetic Events Involved in Development of Wilms' tumor, Genitourinary Anomalies, Hemihypertrophy and Beckwith-Wiedemann, and/or Aniridia	Characterize genetic events by a combined molecular biology/epidemiologic approach	32 Years (Descriptive data collected using questionnaires)

External Links

•   University of Texas MD Anderson Cancer Center Website