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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 21, 2014