ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

Официальное название

Machine Learning Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER-2-Targeted Therapies

Обзор

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.

Первичные конечные точки

• Incidence of cardiotoxicity at 12 months [Срок оценки: 12 months after initiation of anthracycline or HER2-targeted therapy.]

Вторичные конечные точки (3)

• Predictive performance of machine learning-derived cardiotoxicity risk score [Срок оценки: 12 months after initiation of anthracycline or HER2-targeted therapy.]
• Comparison of predictive performance with HFA-ICOS risk score and traditional Cox model [Срок оценки: 12 months after initiation of anthracycline or HER2-targeted therapy.]
• Correlation between baseline prognostic factors and cardiotoxicity at 12 months [Срок оценки: 12 months after initiation of anthracycline or HER2-targeted therapy.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• CHU de Caen — Caen

Идентификаторы

NCT: NCT07191730 · 23-0270

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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