Detection of Chemotherapy Induced Cardiotoxicity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
George Washington University
ClinicalTrials.gov Identifier:
NCT00636844
First received: March 10, 2008
Last updated: March 11, 2013
Last verified: August 2012
  Purpose

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


Condition
Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection of Chemotherapy Induced Cardiotoxicity

Further study details as provided by George Washington University:

Primary Outcome Measures:
  • The genetic profile of patients with anthracycline-induced elevation of troponin-I [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assess the genetic profile of patient with anthracycline-induced left ventricular systolic and diastolic dysfunction [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Assess the relationship of quantitative increases of pro-oxidant stress and a specific genetic profile [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Blood sample for analysis of mRNA and oxidative stress markers


Enrollment: 36
Study Start Date: January 2008
Study Completion Date: June 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group A
Patients receiving chemotherapy (anthracycline and/or adjuvant trastuzumab) for the first time

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Oncology clinic patients

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00636844

Locations
United States, District of Columbia
George Washington University
Washington, District of Columbia, United States, 20037
Sponsors and Collaborators
George Washington University
Investigators
Principal Investigator: Jannet Lewis, MD George Washington University
  More Information

No publications provided

Responsible Party: George Washington University
ClinicalTrials.gov Identifier: NCT00636844     History of Changes
Other Study ID Numbers: JL-001
Study First Received: March 10, 2008
Last Updated: March 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by George Washington University:
chemotherapy, cardiotoxicity

ClinicalTrials.gov processed this record on April 17, 2014