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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 17, 2007 | ||||
| Last Updated Date | August 14, 2009 | ||||
| Start Date ICMJE | December 1980 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To find out why some people develop cancers and tumors, why some families have more cancers than others. [ Time Frame: 32 Years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Characterize the genetic events involved in the development of Wilms' tumor, genitourinary anomalies, hemihypertrophy, and Beckwith-Wiedemann by a combined molecular biology/epidemiologic approach. [ Time Frame: 30 Years ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00503893 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
To study whether certain genes or regions of DNA affect a person's risk of getting cancer. [ Time Frame: 32 Years ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Characterize the genetic events involved in the development of aniridia by a combined molecular biology/epidemiologic approach. [ Time Frame: 30 Years ] [ Designated as safety issue: No ] | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Genetics of Wilms' Tumor and/or the Associated Conditions of Aniridia, Hemihypertrophy, and Genitourinary Anomalies | ||||
| Official Title ICMJE | Genetics of Wilms' Tumor and/or the Associated Conditions of Aniridia, Hemihypertrophy, and Genitourinary Anomalies | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Family-Based, Prospective | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | Familial and Sporadic Wilm's tumor, genitourinary anomalies, Beckwith-Wiedemann hemihypertrophy and/or aniridia. | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 1500 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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. |
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00503893 | ||||
| Responsible Party | Louise C. Strong, MD/Professor, U.T.M.D. Anderson Cancer Center | ||||
| Study ID Numbers ICMJE | P80-099 | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | M.D. Anderson Cancer Center | ||||
| Verification Date | August 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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