Back to resultsNational Wilm's Tumor Study Late Effects
Primary Purpose
Wilm's Tumor
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
none, screening only
Sponsored by
About this trial
This is an interventional screening trial for Wilm's Tumor focused on measuring late effects
Eligibility Criteria
Inclusion Criteria: Previously enrolled in NWTS 5.
Sites / Locations
- Children's Healthcare of Atlanta
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
screening
Arm Description
this is a screening study and no intervention.
Outcomes
Primary Outcome Measures
To determine if survivors from Wilms tumors or their offspring are at risk for adverse medical conditions.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00228696
Brief Title
National Wilm's Tumor Study Late Effects
Official Title
National Wilm's Tumor Study Late Effects
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Withdrawn
Why Stopped
national study, local site not responsible for results/analysis
Study Start Date
September 2005 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wilm's Tumor
Keywords
late effects
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
screening
Arm Type
No Intervention
Arm Description
this is a screening study and no intervention.
Intervention Type
Other
Intervention Name(s)
none, screening only
Intervention Description
Screening protocol with no intervention
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Previously enrolled in NWTS 5.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Katzenstein, MD
Organizational Affiliation
Children's Healthcare of Atlanta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
Learn more about this trial
National Wilm's Tumor Study Late Effects
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