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Genetics of Wilms' Tumor and/or the Associated Conditions of Aniridia, Hemihypertrophy, and Genitourinary Anomalies
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Purpose
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 | Intervention |
|---|---|
| Wilms' Tumor Aniridia | Behavioral: Questionnaire Other: Blood specimen |
| Study Type: | Observational |
| 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) ]Characterize genetic events by a combined molecular biology/epidemiologic approach
Biospecimen Retention: Samples With DNA
| Estimated Enrollment: | 1500 |
| Actual Study Start Date: | December 1980 |
| Estimated Study Completion Date: | December 2018 |
| Estimated Primary Completion Date: | December 2018 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Wilm's Tumor PO1
Familial and Sporadic Wilm's tumor, genitourinary anomalies, Beckwith-Wiedemann hemihypertrophy and/or aniridia.
|
Behavioral: Questionnaire
Questionnaire regarding medical history and family medical history that will take about 1 hour to complete.
Other Name: Survey
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.
|
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| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
Additional Information:
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00503893 History of Changes |
| Other Study ID Numbers: |
P80-099 P01CA034936-23 ( U.S. NIH Grant/Contract ) |
| Study First Received: | July 17, 2007 |
| Last Updated: | July 12, 2017 |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by M.D. Anderson Cancer Center:
|
Wilms' Tumor Genitourinary Anomalies Beckwith-Wiedemann Hemihypertrophy Aniridia Questionnaire |
Additional relevant MeSH terms:
|
Wilms Tumor Congenital Abnormalities Aniridia Neoplasms, Complex and Mixed Neoplasms by Histologic Type Neoplasms Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Neoplastic Syndromes, Hereditary Kidney Diseases Urologic Diseases Genetic Diseases, Inborn Eye Abnormalities Eye Diseases Eye Diseases, Hereditary Iris Diseases Uveal Diseases |
ClinicalTrials.gov processed this record on July 14, 2017