Clinical trial NCT00503893: Genetics of Wilms' Tumor and/or the Associated Conditions of Aniridia, Hemihypertrophy, and Genitourinary Anomalies
Official title: Genetics of Wilms' Tumor and/or the Associated Conditions of Aniridia, Hemihypertrophy, and Genitourinary Anomalies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Wilms' Tumor
Aniridia
Keywords: Wilms' Tumor
Genitourinary Anomalies
Beckwith-Wiedemann Hemihypertrophy
Aniridia
Questionnaire
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-07-19
Enrollment: 295
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with familial and sporadic Wilm's tumor, genitourinary anomalies, Beckwith-Wiedemann hemihypertrophy and/or aniridia, and family members of patients.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Genetic Events Involved in Development of Wilms' tumor, Genitourinary Anomalies, Hemihypertrophy and Beckwith-Wiedemann, and/or Aniridia
timeFrame: 32 Years (Descriptive data collected using questionnaires)
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Louise C. Strong, MD
role: PRINCIPAL_INVESTIGATOR
References: