Correlation Between Genetic Variants and Long-term Cardiac Effects Induced by Doxorubicin in Breast Cancer Patients
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|ClinicalTrials.gov Identifier: NCT02078388|
Recruitment Status : Unknown
Verified March 2014 by Haematology-Oncology, National University Hospital, Singapore.
Recruitment status was: Recruiting
First Posted : March 5, 2014
Last Update Posted : March 5, 2014
The purpose of this study is to identify the genetic variants that are associated with higher risk of doxorubicin-induced cardiotoxicity can contribute towards developing a predictive algorithm comprising both clinical and genetic factors to select patients who should avoid treatment with anthracyclines.
Hypothesis of this study is certain functional variants in genes that encode for metabolizing enzymes and/or targets in the doxorubicin pharmacology pathway may increase the risk of doxorubicin-induced cardiomyopathy
|Condition or disease||Intervention/treatment|
|Breast Cancer||Drug: Doxorubicin|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||October 2015|
Breast cancer patients who received at least one cycle of doxorubicin-containing adjuvant chemotherapy for treatment of early stage breast cancer at least 12 months ago and who had a pre-doxorubicin echocardiography done at NUHS will be enrolled. Study subjects will donate one sample of blood (20ml) for genetic and biomarker studies related to breast cancer and anthracyclines pharmacodynamics. An echocardiography will be performed to measure left ventricular ejection fraction, and compared with the subject's pre-doxorubicin echocardiography done at NUH. Correlative analysis will be performed between genetic variants and left ventricular ejection change.
- Change the functional variants in genes involved in doxorubicin pharmacology with doxorubicin-induced cardiomyopathy in adult breast cancer survivors. [ Time Frame: 1 year ]Identification of genetic variants that are associated with higher risk of doxorubicin-induced cardiotoxicity can contribute towards developing a predictive algorithm comprising both clinical and genetic factors to select patients who should avoid treatment with anthracyclines.
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02078388
|Contact: Soo Chin Lee, MBBS||6779 email@example.com|
|National University Hospital||Recruiting|
|Singapore, Singapore, 119074|
|Contact: Soo Chin Lee, MBBS (65) 6779 5555 firstname.lastname@example.org|
|Principal Investigator: Soo Chin Lee, MBBS|
|Principal Investigator:||Soo Chin Lee, MBBS||National University Hospital, Singapore|