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Detection of Chemotherapy Induced Cardiotoxicity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00636844
First Posted: March 17, 2008
Last Update Posted: March 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
George Washington University
  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 ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: George Washington University
ClinicalTrials.gov Identifier: NCT00636844     History of Changes
Other Study ID Numbers: JL-001
First Submitted: March 10, 2008
First Posted: March 17, 2008
Last Update Posted: March 13, 2013
Last Verified: August 2012

Keywords provided by George Washington University:
chemotherapy, cardiotoxicity

Additional relevant MeSH terms:
Cardiotoxicity
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries