National Wilm's Tumor Study Late Effects | NCT00228696

Studies
National Wilm's Tumor Study Late Effects

NCT00228696

Sponsor

Emory University

Status

Withdrawn

Last Update Posted

Nov 26, 2013Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Wilm's Tumor

Interventions

none, screening only

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

national study, local site not responsible for results/analysis

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Dec 2010Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

Sep 27, 2005

First Submission Date that Met QC Criteria

Sep 27, 2005

First Posted Date

Sep 29, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 23, 2013

Last Update Posted Date

Nov 26, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
screening	No Intervention	this is a screening study and no intervention.	Other: none, screening only

Interventions

Name	Type	Description	Arm Group Labels	Other Names
none, screening only	Other	Screening protocol with no intervention	screening

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine if survivors from Wilms tumors or their offspring are at risk for adverse medical conditions.		1 year after closure of study

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Previously enrolled in NWTS 5.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Howard Katzenstein, MD	Children's Healthcare of Atlanta	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Healthcare of Atlanta		Atlanta	Georgia	30322	United States

Condition Browse Module

MeSH Terms

ID	Term
D009396	Wilms Tumor

Ancestor Terms

ID	Term
D018193	Neoplasms, Complex and Mixed
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D007680	Kidney Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided