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Detection of Chemotherapy Induced Cardiotoxicity

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ClinicalTrials.gov Identifier: NCT00636844
Recruitment Status : Completed
First Posted : March 17, 2008
Last Update Posted : March 13, 2013
Sponsor:
Information provided by (Responsible Party):
George Washington University

Tracking Information
First Submitted Date March 10, 2008
First Posted Date March 17, 2008
Last Update Posted Date March 13, 2013
Study Start Date January 2008
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 14, 2008)
The genetic profile of patients with anthracycline-induced elevation of troponin-I [ Time Frame: one year ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00636844 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 14, 2008)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Detection of Chemotherapy Induced Cardiotoxicity
Official Title Detection of Chemotherapy Induced Cardiotoxicity
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood sample for analysis of mRNA and oxidative stress markers
Sampling Method Non-Probability Sample
Study Population Oncology clinic patients
Condition Cancer
Intervention Not Provided
Study Groups/Cohorts Group A
Patients receiving chemotherapy (anthracycline and/or adjuvant trastuzumab) for the first time
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 11, 2013)
36
Original Estimated Enrollment
 (submitted: March 14, 2008)
50
Actual Study Completion Date June 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00636844
Other Study ID Numbers JL-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party George Washington University
Study Sponsor George Washington University
Collaborators Not Provided
Investigators
Principal Investigator: Jannet Lewis, MD George Washington University
PRS Account George Washington University
Verification Date August 2012