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National Wilm's Tumor Study Late Effects

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00228696
Recruitment Status : Withdrawn (national study, local site not responsible for results/analysis)
First Posted : September 29, 2005
Last Update Posted : November 26, 2013
Sponsor:
Information provided by (Responsible Party):
Howard Katzenstein, Emory University

Study Description
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Brief Summary:
The Late Effects Study is being conducted in order to answer scientific questions and to serve as a resource for Wilms tumor patients and their families. Patients must have been enrolled on the NWTS-5 protocol in order to be eligible for this study.

Condition or disease Intervention/treatment Phase
Wilm's Tumor Other: none, screening only Not Applicable

Detailed Description:
The Late Effects Study is being conducted in order to answer scientific questions and to serve as a resource for Wilms tumor patients and their families. Although most people in this study enjoy good health, some may be at risk for certain health conditions. We are collecting information from as many participants as possible in order to determine if they or their offspring are at risk for adverse medical conditions. If there is more than one case of Wilms tumor in a given family, we plan to work with geneticists to try to estimate heritability and recurrence risks.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: National Wilm's Tumor Study Late Effects
Study Start Date : September 2005
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Wilms Tumor

Arms and Interventions
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Arm Intervention/treatment
No Intervention: screening
this is a screening study and no intervention.
 Other: none, screening only
Screening protocol with no intervention


Outcome Measures
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Primary Outcome Measures :
  1. To determine if survivors from Wilms tumors or their offspring are at risk for adverse medical conditions. [ Time Frame: 1 year after closure of study ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Previously enrolled in NWTS 5.

Contacts and Locations
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Information from the National Library of Medicine

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): NCT00228696


Locations
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United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Howard Katzenstein, MD Children's Healthcare of Atlanta
More Information
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Responsible Party: Howard Katzenstein, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT00228696     History of Changes
Other Study ID Numbers: IRB00024842
First Posted: September 29, 2005    Key Record Dates
Last Update Posted: November 26, 2013
Last Verified: November 2013
Keywords provided by Howard Katzenstein, Emory University:
late effects
Additional relevant MeSH terms:
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Wilms Tumor
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