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NCT Number: NCT07058454

Multicenter Prospective Observational Study of Cardiotoxicity in Patients Receiving Targeted Cancer Therapies

This study will prospectively monitor cancer patients receiving chemotherapy (including molecular targeted therapies) for cardiovascular adverse events using biomarkers and imaging. The goal is to develop a predictive model for major adverse cardiovascular events (MACE) in this population by integrating both local factors (e.g. central venous catheter-related thrombosis) and systemic factors (e.g. age, comorbidities, genetic predisposition). An active surveillance system employing periodic cardiac evaluations (ECG, echocardiography) and biomarker measurements (troponin T, NT-proBNP) will enable early detection of cardiotoxic effects. The impact of these adverse events and the monitoring strategy on patients' quality of life will also be assessed.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 5106555, China

Location status: Recruiting

Location contact

xiaoyan li

CONTACT

[email protected]

13609066172

About this study

Cancer patients are at heightened risk of cardiovascular complications due to both their disease and its treatments. Many chemotherapeutic and targeted agents (e.g. anthracyclines, trastuzumab, bevacizumab, tyrosine kinase inhibitors) carry cardiotoxic potential, leading to diverse manifestations of MACE such as heart failure, arrhythmias, ischemic heart disease, valvular dysfunction, hypertension, thromboembolism, and others. As cancer survival improves and newer therapies are widely used, the incidence of treatment-related cardiac toxicity continues to rise. Early cardiotoxic changes are often subclinical, making proactive monitoring essential. Research has shown that cardiac biomarkers can rise before left ventricular ejection fraction declines, enabling "pre-symptomatic" detection of cardiotoxicity. By quantitatively analyzing the predictive value of each indicator for MACE, the study aims to construct a comprehensive risk prediction model for precise cardiovascular risk evaluation in cancer patients. Both local risk factors (e.g., indwelling catheter-related thrombosis) and systemic factors (e.g., age, hypercoagulability, body mass index) will be incorporated, reflecting the interplay of factors contributing to MACE. Genetic biomarkers will also be explored: blood samples are collected for genomic analysis (such as SNP genotyping and whole genome sequencing) to identify genetic polymorphisms associated with increased susceptibility to therapy-related MACE. By comparing patients who develop cardiovascular events to those who do not, we will characterize the incidence, timing, affected organs, and clinical presentation of MACE in cancer patients. Patient-reported quality of life will be evaluated using validated questionnaires, to determine how the occurrence of adverse cardiovascular events (and the implementation of active monitoring) affects daily functioning and overall well-being. Ultimately, this study's findings will provide a scientific basis for individualized risk stratification and preventive interventions in cardio-oncology, supporting optimized clinical strategies to mitigate cardiovascular risk without compromising effective cancer treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1.Adults (age > 18 years) with a pathologically confirmed malignant tumor (any type of cancer); 2.Currently receiving or planning to receive chemotherapy (including regimens containing molecular targeted drugs) as adjuvant treatment for cancer; 3.Willing and able to participate in the study with provision of informed consent, and agreeable to provide required clinical data and biological samples.

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Exclusion criteria

  • Incomplete basic patient information or medical records (missing key data necessary for the study);
  • Failure to complete the full course of planned chemotherapy at the study center (e.g., patient did not adhere to or finish all cycles of adjuvant chemotherapy at our institution);
  • History of severe acute cardiovascular or cerebrovascular events within 6 months prior to enrollment, including acute heart failure, acute myocardial infarction, acute intracerebral hemorrhage (stroke), malignant arrhythmia, or New York Heart Association (NYHA) Class IV/V heart failure;
  • Missing essential pre- or post-chemotherapy evaluations: patients who did not undergo complete baseline or end-of-treatment assessments (such as blood routine, hepatic/renal function, coagulation profile, cardiac enzymes (troponin T), NT-proBNP (or BNP), 12-lead ECG, and echocardiogram)

Treatment and study plan

Primary outcomes

  1. Incidence of New Onset Major Adverse Cardiovascular Events (MACE) by End of Chemotherapy

    Time frame: From initiation of chemotherapy to end of adjuvant chemotherapy (approximately up to 6 months per patient).

    Occurrence of any new cardiovascular adverse event from start of chemotherapy to the completion of the chemotherapy regimen. "MACE" is defined per ESC guidelines to include major cardiac events such as new myocardial dysfunction, symptomatic heart failure, coronary artery disease (e.g. myocardial infarction), clinically significant valvular disease, arrhythmia (e.g. atrial fibrillation), new or worsening hypertension, thromboembolic events (including deep vein thrombosis or pulmonary embolism), peripheral vascular disease, pulmonary hypertension, or pericardial disease. Any such event recorded on electrocardiogram, cardiac ultrasound (echocardiography), or via cardiac enzymes (troponin T) and biomarkers (NT-proBNP/BNP) by the end of the adjuvant chemotherapy cycle, relative to the patient's pre-treatment baseline, will be counted as an outcome event. (Early cardiovascular events are defined as those occurring during the chemotherapy period.)

Secondary outcomes

  1. Quality of Life Score Change (Baseline to 6 Months Post-treatment)

    Time frame: Baseline pre-therapy and 6 months after completion of chemotherapy.

    Change in patient-reported quality of life from baseline (pre-therapy) to follow-up after therapy completion. Quality of life will be measured using a validated questionnaire (e.g., EORTC QLQ-C30 or similar cancer-specific QoL instrument) at study entry and at 6 months after the last chemotherapy cycle. The difference in global health/QoL scores and functional subscales will be analyzed to determine the impact of any adverse events and the monitoring program on patients' quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

xiaoyan li

CONTACT

[email protected]

13609066172

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Official study title

Development of an Active Surveillance System for Adverse Reactions to Molecular Targeted Drugs Based on Biomarkers and Personalized Medicine and Its Impact on Patient Quality of Life

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 10, 2025
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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