National Wilm's Tumor Study Late Effects
Recruitment status was Recruiting
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Purpose
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 | Intervention |
|---|---|
|
Wilm's Tumor |
Other: none, screening only |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Screening |
| Official Title: | National Wilm's Tumor Study Late Effects |
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: screening
this is a screening study and no intervention.
|
Other: none, screening only
Screening protocol with no intervention
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Previously enrolled in NWTS 5.
Contacts and Locations| Contact: Sindy Midoro | 404-785-1441 | sindy.midoro@choa.org |
| United States, Georgia | |
| Children's Healthcare of Atlanta | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Sindy Midoro 404-785-1441 sindy.midoro@choa.org | |
| Principal Investigator: Howard Katzenstein, MD | |
| Principal Investigator: | Howard Katzenstein, MD | Children's Healthcare of Atlanta |
More Information
No publications provided
| Responsible Party: | Howard Katzenstein, MD, Children's Healthcare of Atlanta/Emory University |
| ClinicalTrials.gov Identifier: | NCT00228696 History of Changes |
| Other Study ID Numbers: | 199-96 |
| Study First Received: | September 27, 2005 |
| Last Updated: | September 24, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Emory University:
|
late effects |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on June 17, 2013