Detection of Chemotherapy Induced Cardiotoxicity | NCT00636844

Studies
Detection of Chemotherapy Induced Cardiotoxicity

NCT00636844

Sponsor

George Washington University

Status

Completed

Last Update Posted

Mar 13, 2013Estimated

Enrollment

36Actual

Phase

Not provided

Conditions

Cancer

Interventions

Not provided

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

Aug 2012

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

Jan 2008

Primary Completion Date

Dec 2011Actual

Completion Date

Jun 2012Actual

First Submitted Date

Mar 10, 2008

First Submission Date that Met QC Criteria

Mar 14, 2008

First Posted Date

Mar 17, 2008Estimated

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

Mar 11, 2013

Last Update Posted Date

Mar 13, 2013Estimated

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

To identify patients that are at risk of heart damage after receiving chemotherapy (adriamycin).

Detailed Description

To identify patients at risk of development of heart damage after receiving chemotherapy by obtaining the genetic profile of those who show: elevation of troponin, left ventricular systolic and diastolic dysfunction, and pro-oxidant stress markers.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A		Patients receiving chemotherapy (anthracycline and/or adjuvant trastuzumab) for the first time

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The genetic profile of patients with anthracycline-induced elevation of troponin-I		one year

Secondary Outcomes

Measure	Description	Time Frame
Assess the genetic profile of patient with anthracycline-induced left ventricular systolic and diastolic dysfunction		one year
Assess the relationship of quantitative increases of pro-oxidant stress and a specific genetic profile		one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

undergoing anthracycline and/or trastuzumab therapy for the first time

Exclusion Criteria:

abnormal ventricular ejection fraction
past history of, or active cardiac disease including: MI, CHF, angina, arrhythmia requiring medication, valvular disease, uncontrolled systemic hypertension

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Oncology clinic patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jannet Lewis, MD	George Washington University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
George Washington University		Washington D.C.	District of Columbia	20037	United States

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms
D066126	Cardiotoxicity

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided