|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00503893 |
Purpose
The overall goals are to characterize the genetic events involved in the development of Wilms' tumor, genitourinary anomalies, hemihypertrophy and Beckwith-Wiedemann, and/or aniridia by a combined molecular biology/epidemiologic approach. The study involves investigation of patients with familial and sporadic Wilms' tumor, genitourinary anomalies Beckwith-Wiedemann hemihypertrophy and/or aniridia.
| Condition | Intervention |
|---|---|
|
Wilms' Tumor Aniridia |
Behavioral: Questionnaire Other: Blood specimen |
| Study Type: | Observational |
| Study Design: | Family-Based, Prospective |
| Official Title: | Genetics of Wilms' Tumor and/or the Associated Conditions of Aniridia, Hemihypertrophy, and Genitourinary Anomalies |
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.
| Estimated Enrollment: | 1500 |
| Study Start Date: | December 1980 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
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: Blood specimen
Blood (about 10 teaspoons) will be drawn from a vein for genetic testing. The blood may be drawn more than one time.
|
Treatment: Researchers sometimes look for causes of cancer or cancer risk by studying the characteristics of certain groups of people, particularly families. This involves collecting medical information and using it to look for a pattern of characteristics which may point to cancer risks. The goal of this study is to use information from blood and tissue samples, as well as medical history, to look for such a pattern.
If you choose to take part in this study, blood (about 10 teaspoons) will be drawn from a vein for genetic testing. The blood may be drawn more than one time. If this is the case, your doctor will discuss any extra blood draws with you.
You will be asked to complete a questionnaire regarding your medical history and family medical history. The questionnaire will take about 1 hour to complete. You will also be asked to allow members of the study staff to review your medical records. Information in medical records can be used in research to learn about, prevent, or treat cancer.
You will be asked allow members of 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 applies to any past or future surgical procedures, as well as any tissue being stored in another facility or at UTMDACC. No new surgeries or biopsies will be needed, and no surgical procedures will be performed for research purposes only. This part of the study only has to do with tissue that is left over from your standard procedures and would otherwise be banked or thrown away.
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 UTMDACC. 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 UTMDACC, including research involving your information, tissue samples, and/or bodily fluids, must first be approved by the IRB.
You will be contacted through 2012, so that the study staff can update your medical history and information.
This is an investigational study. About 1500 patients and family members will take part in this study. All will be enrolled at M.D. Anderson.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Patients with familial and sporadic Wilm's tumor, genitourinary anomalies, Beckwith-Wiedemann hemihypertrophy and/or aniridia, and family members of patients.
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 Locations| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Louise C. Strong, MD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Louise C. Strong, MD/Professor ) |
| Study ID Numbers: | P80-099 |
| Study First Received: | July 17, 2007 |
| Last Updated: | August 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00503893 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Wilms' Tumor Genitourinary Anomalies Beckwith-Wiedemann Hemihypertrophy Aniridia Questionnaire |
|
Uveal Diseases Neoplasms by Histologic Type Eye Diseases Urogenital Neoplasms Urologic Neoplasms Eye Abnormalities Neoplasms Neoplastic Syndromes, Hereditary Neoplasms by Site Urogenital Abnormalities |
Iris Diseases Urologic Diseases Genetic Diseases, Inborn Kidney Neoplasms Wilms Tumor Eye Diseases, Hereditary Kidney Diseases Aniridia Congenital Abnormalities Neoplasms, Complex and Mixed |
