Predicting Heart Damage From Certain Cancer Treatments Using Machine Learning
Develops a computer-based score to predict heart problems in adults receiving certain cancer drugs.
Key facts
- Who runs it
- University Hospital, Caen
- Where
- Caen, FranceSee the site
- Trial code
- Registry title
- ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies
- Status
- Recruiting
- People taking part
- 600 people, planned
- Started
- 29 Oct 2025
- Expected to end
- Nov 2028
- Type of study
- Observational
- Record updated
- 19 March 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with cancer who will start anthracycline or HER2-targeted treatment and are followed in a cardio-oncology clinic. It studies heart damage from these treatments.
- Age
- 18 years or older
- Sex
- All
- Disease stage
- Cancer patients about to start anthracycline and/or HER2-targeted therapy, seen for a baseline heart check before treatment.
- Earlier treatment
- Earlier cancer treatments that may harm the heart, or chest radiotherapy, are allowed.
Main reasons for not taking part
- Not covered by the French national health insurance system (Sécurité Sociale)
- The 12-month follow-up is planned at a different center than the one doing the baseline check
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in France
- CHU de CAENCaen, FranceContact: Damien Legallois, MDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Machine Learning Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER-2-Targeted Therapies
- Plain-language title
- Predicting Heart Damage From Certain Cancer Treatments Using Machine LearningGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 19 March 2026