An observational study in Cardiotoxicity, sponsored by Beneficência Portuguesa de São Paulo. Recruiting at 6 sites in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-23.
Sponsored by Beneficência Portuguesa de São Paulo · Observational
To evaluate the use of a pharmacogenetic and pharmacoepigenetic panel for predicting chemotherapy- and immunotherapy-induced cardiotoxicity in cancer patients.
Cardiotoxicity induced by cancer therapies, such as chemotherapy and immunotherapy, represents a critical health challenge, as it may result in left ventricular dysfunction and heart failure, complications associated with high mortality rates. This risk is particularly elevated in patients treated with anthracyclines, which are widely used in cancers such as breast cancer. The mortality associated with post-treatment cardiac dysfunction, together with its substantial economic burden on the healthcare system, highlights the urgent need for early identification and prevention of cardiotoxicity.
The primary objective of this study is to develop a pharmacogenomic panel capable of predicting cardiotoxicity in patients receiving chemotherapy or immunotherapy, enabling preventive interventions before the initiation of cancer treatment. To achieve this, 1,000 breast cancer patients aged 18 years or older who are scheduled to begin cancer therapy will be enrolled. Patients with a left ventricular ejection fraction (LVEF) \< 50%, those who have undergone chemotherapy and/or radiotherapy within the previous year, patients with chronic kidney disease and a glomerular filtration rate below 30 mL/min/1.73 m², uncontrolled hypertension, or complex congenital heart disease will be excluded.
Participants will be monitored for 12 months and will undergo cardiologic assessments, including electrocardiography, echocardiography with strain analysis, and measurement of Pro-BNP, BNP, Troponin I, and Troponin T levels, as well as blood sample collection. Blood samples will be used for exome sequencing, miRNA sequencing, plasma protein quantification, lipid peroxide formation analysis, metabolomic and proteomic studies, and measurement of plasma drug concentrations. Exome libraries will be prepared using the Illumina® DNA Prep with Exome 2.0 Plus Enrichment kit, while plasma-derived miRNA libraries will be prepared using the QIAseq miRNA Library Kit. Sequencing will be performed on the NextSeq 2000 Sequencing System.
In addition, the plasma proteins angiopoietin-2, VCAM-1, and VEGF-A will be quantified using the Luminex® Multiplex Assay platform, and lipid peroxide formation will be monitored as a marker of oxidative stress. Selected genetic variants and miRNAs will be validated by quantitative PCR (qPCR). Furthermore, metabolomic and proteomic analyses will be conducted to characterize cardiotoxicity. This comprehensive set of analyses, combined with continuous patient monitoring throughout treatment, will enable detailed characterization of cardiotoxicity and facilitate comparisons between patient groups for subsequent genotyping analyses.
The relevance of this research to Brazil's Unified Health System (SUS) is substantial, as it may support the implementation of safer and more effective cancer treatment protocols, reducing the incidence of cardiotoxicity and the resulting hospitalizations. The application of precision medicine strategies has the potential to improve patients' quality of life while optimizing healthcare resources and reducing costs associated with the management of chemotherapy- and immunotherapy-induced cardiovascular complications.
262 studies on the registry are indexed under Cardiotoxicity; 75 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 111 across 124 observational studies indexed under Cardiotoxicity.
Browse Cardiotoxicity studies →Beneficência Portuguesa de São Paulo is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
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A prospective cohort of adult breast cancer patients receiving cardiotoxic cancer therapies, followed for cardiovascular assessment and multi-omics profiling to identify predictors of treatment-related cardiotoxicity.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This cohort will consist of participants with cardiotoxicity after one year of treatment and will be used for exome analysis and miRNA sequencing. In this cohort, metabolomic and proteomic profiling, drug concentration measurements, and assessments of immune function and inflammation will also be be performed.
This cohort will consist of participants with cardiotoxicity after one year of treatment and will be used to validate the genetic variants identified through exome analysis, as well as the miRNAs selected following sequencing.
This cohort will consist of participants without cardiotoxicity after one year of treatment and will be used for exome analysis and miRNA sequencing. In this cohort, metabolomic and proteomic profiling, drug concentration measurements, and assessments of immune function and inflammation will also be be performed.
This cohort will consist of participants without cardiotoxicity after one year of treatment and will be used to validate the genetic variants identified through exome analysis, as well as the miRNAs selected following sequencing.
Cardiotoxicity
Throughout treatment and follow-up, cardiotoxicity will be defined according to the criteria established by the 2022 European Society of Cardiology (ESC) Cardio-Oncology Guidelines.
Time frame: 1 year
Plan to share: Undecided
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Beneficência Portuguesa de São Paulo