Detection of Chemotherapy Induced Cardiotoxicity
This study has been completed.
Sponsor:
George Washington University
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
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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 May 16, 2013