Genetics of Wilms' Tumor and/or the Associated Conditions of Aniridia, Hemihypertrophy, and Genitourinary Anomalies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00503893|
Recruitment Status : Recruiting
First Posted : July 19, 2007
Last Update Posted : July 14, 2017
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|
|Wilms' Tumor Aniridia||Behavioral: Questionnaire Other: Blood specimen|
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 Type :||Observational|
|Estimated Enrollment :||1500 participants|
|Official Title:||Genetics of Wilms' Tumor and/or the Associated Conditions of Aniridia, Hemihypertrophy, and Genitourinary Anomalies|
|Actual Study Start Date :||December 1980|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
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.
- 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) ]Characterize genetic events by a combined molecular biology/epidemiologic approach
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00503893
|Contact: Louise C. Strong, MD||713-792-7555|
|United States, Texas|
|University of Texas 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|