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

NCT07191730 | Recruiting

• 1 other identifier: 23-0270
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiotoxicity; Heart Failure; Neoplasms; Breast Neoplasms

Keywords

Cancer Therapy-Related Cardiac Dysfunction; Anthracyclines; HER2-targeted Therapy; Cardio-Oncology; Machine Learning

Outcome Measures

Primary Outcomes (1)

• Incidence of cardiotoxicity at 12 months

  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.

  12 months after initiation of anthracycline or HER2-targeted therapy.

Secondary Outcomes (3)

• Predictive performance of machine learning-derived cardiotoxicity risk score

  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.

• Correlation between baseline prognostic factors and cardiotoxicity at 12 months

  12 months after initiation of anthracycline or HER2-targeted therapy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with cancer scheduled to receive anthracyclines and/or HER2-targeted therapy, referred to cardio-oncology clinics in 15 participating French centers for a baseline pre-treatment evaluation and planned follow-up. Consecutive eligible patients will be enrolled over a 12-month inclusion period, with a 12-month follow-up.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

CHU de Caen

Caen, France

RECRUITING

MeSH Terms

Conditions

Cardiotoxicity; Heart Failure; Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Damien Legallois, MD, PhD

CONTACT

33231064418; damien.legallois@unicaen.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 25, 2025
• Study Start: October 29, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

FR (1)