- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00228696
National Wilm's Tumor Study Late Effects
November 23, 2013 updated by: Howard Katzenstein, Emory University
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.
Study Overview
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 Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Georgia
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Atlanta, Georgia, United States, 30322
- Children's Healthcare of Atlanta
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Previously enrolled in NWTS 5.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: screening
this is a screening study and no intervention.
|
Screening protocol with no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
1 year after closure of study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Howard Katzenstein, MD, Children's Healthcare of Atlanta
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (Anticipated)
December 1, 2010
Study Completion (Anticipated)
December 1, 2011
Study Registration Dates
First Submitted
September 27, 2005
First Submitted That Met QC Criteria
September 27, 2005
First Posted (Estimate)
September 29, 2005
Study Record Updates
Last Update Posted (Estimate)
November 26, 2013
Last Update Submitted That Met QC Criteria
November 23, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00024842
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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