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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Recruitment Status : Withdrawn (national study, local site not responsible for results/analysis)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

Tracking Information
First Submitted Date  ICMJE September 27, 2005
First Posted Date  ICMJE September 29, 2005
Last Update Posted Date November 26, 2013
Study Start Date  ICMJE September 2005
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2009)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 27, 2005)
  • To determine if participant's offsprings are at risk for adverse medical conditions.
  • To answer questions about long-term effects of treatment for Wilm's tumors.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE National Wilm's Tumor Study Late Effects
Official Title  ICMJE National Wilm's Tumor Study Late Effects
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Wilm's Tumor
Intervention  ICMJE Other: none, screening only
Screening protocol with no intervention
Study Arms  ICMJE No Intervention: screening
this is a screening study and no intervention.
Intervention: Other: none, screening only
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 23, 2013)
0
Original Enrollment  ICMJE
 (submitted: September 27, 2005)
80
Estimated Study Completion Date  ICMJE December 2011
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Previously enrolled in NWTS 5.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00228696
Other Study ID Numbers  ICMJE IRB00024842
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Howard Katzenstein, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Howard Katzenstein, MD Children's Healthcare of Atlanta
PRS Account Emory University
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP