Vascular Endothelial Inflammation and Dysfunction in Pedi... | NCT02032121

Studies
Vascular Endothelial Inflammation and Dysfunction in Pediatric Long-term Cancer Survivors

NCT02032121

Sponsor

University of Miami

Status

Completed

Last Update Posted

Sep 9, 2015Estimated

Enrollment

6Actual

Phase

Not Applicable

Conditions

Cancer Survivor
Pediatric Cancer

Interventions

Blood specimen
Echocardiography

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

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Aug 2015Actual

Completion Date

Aug 2015Actual

First Submitted Date

Jan 8, 2014

First Submission Date that Met QC Criteria

Jan 8, 2014

First Posted Date

Jan 9, 2014Estimated

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

Sep 8, 2015

Last Update Posted Date

Sep 9, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Survivors of childhood cancer have an increased risk of death from cardiovascular disease due to both the therapies they received while undergoing treatment and diet and lifestyle factors. The nature of cardiovascular risk and the interaction between treatment affects and cardiovascular risk factors is unknown. We propose to study vascular inflammatory markers as well as measure of blood vessel stiffness (both of which are predictive of early heart disease) in 100 pediatric cancer survivors and 100 control children. Characterization of vascular inflammation and stiffness in long-term survivors will allow for the development of future interventions to decrease inflammation through both pharmacologic and lifestyle modifications.

Detailed Description

Not provided

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

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention procedures	Experimental	All the procedures will be completed for every subject	Procedure: Blood specimen Procedure: Echocardiography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood specimen	Procedure		Intervention procedures
Echocardiography

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vascular Inflammation	All study procedures to assess vascular inflammation will be assessed through specimen sample collection and through procedures such as (echocardiograph)	single time point at initial visit

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

6-30 years of age
2 years from the completion of therapy for cancer
free of active disease

Exclusion Criteria:

<6 or > 30 years of age
current cancer treatment or inside of 2 years post treatment
Active disease/infection

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

30 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tracie L Miller, MD, SM	University of Miami	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Miami, MIller School of Medicine		Miami	Florida	33136	United States

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection
D059168	Carotid Intima-Media Thickness
D015519	Bone Density

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided