Detection of Chemotherapy Induced Cardiotoxicity

Completed

• Conditions: Cancer

• Registration Number: NCT00636844
• Lead Sponsor: George Washington University

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-03-10
• Study First Submitted QC: 2008-03-14
• Study First Posted: 2008-03-17
• Primary Completion: 2011-12
• Study Completion: 2012-06
• Status Verified: 2012-08
• Last Update Submitted: 2013-03-11
• Last Update Posted: 2013-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The genetic profile of patients with anthracycline-induced elevation of troponin-I	one year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

George Washington University; 🇺🇸 Washington, District of Columbia, United States