Genetics of Wilms' Tumor and/or the Associated Conditions of Aniridia, Hemihypertrophy, and Genitourinary Anomalies
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.
|Study Design:||Observational Model: Family-Based
Time Perspective: Prospective
|Official Title:||Genetics of Wilms' Tumor and/or the Associated Conditions of Aniridia, Hemihypertrophy, and Genitourinary Anomalies|
- Genetic Events Involved in Development of Wilms' tumor, Genitourinary Anomalies, Hemihypertrophy and Beckwith-Wiedemann, and/or Aniridia [ Time Frame: 32 Years (Descriptive data collected using questionnaires) ] [ Designated as safety issue: No ]Characterize genetic events by a combined molecular biology/epidemiologic approach
Biospecimen Retention: Samples With DNA
Blood sample(s) for genetic testing. Also, tissue samples, and/or bodily fluids (whether healthy or cancerous) left over from surgeries or procedures performed as part of standard care. The purpose of this clinical research study is to find out why some people develop cancers and tumors, why some families have more cancers than others, and whether certain genes or regions of DNA affect a person's risk of getting cancer.
|Study Start Date:||December 1980|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Wilm's Tumor PO1
Familial and Sporadic Wilm's tumor, genitourinary anomalies, Beckwith-Wiedemann hemihypertrophy and/or aniridia.
Questionnaire regarding medical history and family medical history that will take about 1 hour to complete.
Other Name: SurveyOther: Blood specimen
Blood (about 10 teaspoons) will be drawn from a vein for genetic testing. The blood may be drawn more than one time.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00503893
|Contact: Louise C. Strong, MD||713-792-7555|
|United States, Texas|
|UT MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Louise C. Strong, MD|
|Principal Investigator:||Louise C. Strong, MD||M.D. Anderson Cancer Center|