ISRCTN12628444
Active, not recruiting
未知
Development of a program for early diagnosis and treatment of cardiotoxic complications caused by chemotherapy for breast cancer (PREDICATE)
Ministry of Education and Science of the Republic of Kazakhstan0 sites120 target enrollmentJuly 21, 2022
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Early diagnosis and prevention of chemotherapy cardiotoxic effects in breast cancer patients
- Sponsor
- Ministry of Education and Science of the Republic of Kazakhstan
- Enrollment
- 120
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36359556/ (added 10/11/2023) 2021 Results article in https://doi.org/10.23950/jcmk/11412 patients' survival and their cardiovascular system condition (added 10/11/2023) 2023 Results article in https://doi.org/10.23950/jcmk/13325 stratifying patients based on cancer treatment-related cardiovascular disease (added 10/11/2023) 2023 Results article in https://doi.org/10.3390/diagnostics13233557 Role of Clinical Risk Factors and B-Type Natriuretic Peptide in Assessing the Risk of Asymptomatic Cardiotoxicity in Breast Cancer Patients in Kazakhstan (added 04/12/2023)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Verified diagnosis of C50 malignant neoplasm of the breast at any stage (if eligible for chemotherapy), according to the Republican Protocol for Diagnosis and Treatment of Breast Cancer dated March 01, 2019, No. 56, upon admittance to the University's Medical Center
- •2\. Any age
- •3\. Out/inpatient treatment in the Medical Center
- •4\. Targeted therapy upon the confirmed positive Her2 status and/or Anthracyclines administering
- •5\. Simpson left ventricular ejection fraction \=40% without symptoms of heart failure established within 30 days before admission to the chemotherapy division
Exclusion Criteria
- •Current participant exclusion criteria as of 29/07/2022:
- •1\. Coronary heart disease (CHD) progression or congestive heart failure (CHF) decompensation
- •2\. Simpson left ventricular ejection fraction \=40%
- •3\. Any recurrent comorbid pathology decompensation
- •Previous participant exclusion criteria:
- •1\. Presence of recorded cardiotoxic effects of chemotherapy, regardless of the limitation period
- •2\. Coronary heart disease (CHD) progression or congestive heart failure (CHF) decompensation in the previous six months
- •3\. Simpson left ventricular ejection fraction \=40%;
- •4\. Decompensation of comorbid pathology within the previous three months:
- •4\.1\. Endocrine diseases
Outcomes
Primary Outcomes
Not specified
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