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Genetics of Wilms' Tumor and/or the Associated Conditions of Aniridia, Hemihypertrophy, and Genitourinary Anomalies

This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, January 2008

Sponsors and Collaborators: M.D. Anderson Cancer Center
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

Genetics Home Reference related topics:   Beckwith-Wiedemann syndrome    Lenz microphthalmia syndrome    oculofaciocardiodental syndrome    Peters plus syndrome   

MedlinePlus related topics:   Cancer    Wilms' Tumor   

U.S. FDA Resources

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

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

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 2010 (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.

Detailed Description:

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 2009, so that the study staff can update your medical history and information.

This is an investigational study. Study procedures will be provided free of charge. About 1500 patients and family members will take part in this study. All will be enrolled at M.D. Anderson.

This protocol is partially funded by a research grant from the National Cancer Institute (NCI).

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample

Study Population

Patients with familial and sporadic Wilm's tumor, genitourinary anomalies, Beckwith-Wiedemann hemihypertrophy and/or aniridia, and family members of patients.


Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503893

Contacts
Contact: Louise C. Strong, MD     713-792-7555    

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center     Recruiting
      Houston, Texas, United States, 77030
      Principal Investigator: Louise C. Strong, MD            

Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Investigators
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
First Received:   July 17, 2007
Last Updated:   January 10, 2008
ClinicalTrials.gov Identifier:   NCT00503893
Health Authority:   United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Wilms' Tumor  
Genitourinary Anomalies  
Beckwith-Wiedemann Hemihypertrophy  
Aniridia  
Questionnaire  

Study placed in the following topic categories:
Eye Diseases
Wilms' tumor
Urogenital Neoplasms
Renal cancer
Kidney cancer
Urologic Neoplasms
Eye Abnormalities
Urogenital Abnormalities
Neoplastic Syndromes, Hereditary
Urologic Diseases
Genetic Diseases, Inborn
Kidney Neoplasms
Wilms Tumor
Eye Diseases, Hereditary
Kidney Diseases
Aniridia
Congenital Abnormalities
Urinary tract neoplasm

Additional relevant MeSH terms:
Neoplasms
Uveal Diseases
Neoplasms by Site
Neoplasms by Histologic Type
Iris Diseases
Neoplasms, Complex and Mixed

ClinicalTrials.gov processed this record on October 10, 2008




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