Detection of Chemotherapy Induced Cardiotoxicity

March 11, 2013 updated by: George Washington University
To identify patients that are at risk of heart damage after receiving chemotherapy (adriamycin).

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Oncology clinic patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group A
Patients receiving chemotherapy (anthracycline and/or adjuvant trastuzumab) for the first time

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

George Washington University

Investigators

  • Principal Investigator: Jannet Lewis, MD, George Washington University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

March 10, 2008

First Submitted That Met QC Criteria

March 14, 2008

First Posted (Estimate)

March 17, 2008

Study Record Updates

Last Update Posted (Estimate)

March 13, 2013

Last Update Submitted That Met QC Criteria

March 11, 2013

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JL-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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