National Wilm's Tumor Study Late Effects

This study has been withdrawn prior to enrollment.
(national study, local site not responsible for results/analysis)
Sponsor:
Information provided by (Responsible Party):
Howard Katzenstein, Emory University
ClinicalTrials.gov Identifier:
NCT00228696
First received: September 27, 2005
Last updated: November 23, 2013
Last verified: November 2013
  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

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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 ]

Enrollment: 0
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
Criteria

Inclusion Criteria:

Previously enrolled in NWTS 5.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00228696

Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Howard Katzenstein, MD Children's Healthcare of Atlanta
  More Information

No publications provided

Responsible Party: Howard Katzenstein, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT00228696     History of Changes
Other Study ID Numbers: IRB00024842
Study First Received: September 27, 2005
Last Updated: November 23, 2013
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 July 23, 2014