Machine Learning Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER-2-Targeted Therapies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Incidence of cardiotoxicity at 12 months
研究概览
简要总结
Cancer treatments have improved substantially over the past decades, but some effective therapies such as anthracyclines and HER2-targeted agents are associated with severe cardiovascular adverse effects, including heart failure. Existing cardiovascular risk prediction scores have limited evidence in this setting.
The ML-CardioTox study is a prospective, multicenter, observational cohort conducted in 15 centers in France. The primary objective is to develop a one-year prediction score for cancer therapy-related cardiotoxicity using machine learning methods. A dedicated software platform will be used to standardize data collection and support integration of artificial intelligence tools.
A total of 600 patients treated with anthracyclines or HER2-targeted therapies in cardio-oncology clinics will be enrolled over a one-year inclusion period starting in December 2024, with a 12-month follow-up. The primary endpoint is the occurrence of cardiotoxicity as defined by the 2022 European Society of Cardiology guidelines (hospitalization for heart failure, initiation or escalation of diuretic therapy, decline in cardiac function on imaging, or increase in cardiac biomarkers such as troponin or natriuretic peptides).
Secondary objectives include comparison of the predictive performance of the machine learning-derived score with the established HFA-ICOS risk score. Patients will be managed according to routine clinical practice.
This study aims to improve prognostic stratification tools for patients receiving anthracyclines or HER2-targeted therapies, with the goal of better identifying those at high risk of developing cardiotoxicity during follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Planned follow-up in cardio-oncology clinic as part of a baseline pre-treatment evaluation before a sequence of anthracycline and/or HER2-targeted therapy, according to the 2022 ESC recommendations
- •Inclusion regardless of prior exposure to potentially cardiotoxic anticancer therapies or thoracic radiotherapy
排除标准
- •Patients not covered by the French national health insurance system (Sécurité Sociale)
- •Patients for whom 12-month follow-up is planned outside the center performing the baseline pre-treatment evaluation
结局指标
主要结局
Incidence of cardiotoxicity at 12 months
时间窗: 12 months after initiation of anthracycline or HER2-targeted therapy.
Cardiotoxicity defined as a composite outcome, according to the 2022 ESC guidelines: hospitalization for heart failure OR initiation or escalation of diuretic therapy for signs or symptoms of heart failure OR decrease in left ventricular ejection fraction (LVEF) by \>10 percentage points from baseline or to a value \<40% OR relative decrease in global longitudinal strain (GLS) ≥15% from baseline OR new increase in cardiac biomarkers (troponin or NT-proBNP/BNP). Events will be adjudicated by an independent committee.
次要结局
- Predictive performance of machine learning-derived cardiotoxicity risk score(12 months after initiation of anthracycline or HER2-targeted therapy.)
- Correlation between baseline prognostic factors and cardiotoxicity at 12 months(12 months after initiation of anthracycline or HER2-targeted therapy.)
- Comparison of predictive performance with HFA-ICOS risk score and traditional Cox model(12 months after initiation of anthracycline or HER2-targeted therapy.)