Detection and Prevention of Cancer-Related Cardiovascular Toxicity Registry

Recruiting

• Conditions: Cancer Related Cardiovascular Toxicity

• Registration Number: NCT06086132
• Lead Sponsor: University of Bologna

Brief Summary

This study is being done in order to assess the cardiovascular events known as cardiovascular toxicity of chemotherapy agents and radiotherapy protocols in cancer subjects to identify risk prediction, prevention and treatment of cancer therapy-related cardiovascular toxicity and cancer therapy-related cardiac dysfunction

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-11
• Study First Submitted QC: 2023-10-11
• Study First Posted: 2023-10-17
• Study Start: 2025-05-01
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-16
• Last Update Posted: 2025-06-19
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• Age 18 years old or older
• Capable of giving informed consent
• Diagnosis of cancer scheduled for treatment according to treating physician's discretion
• Life expectancy >1 year
• For the prospective validation of HFA-ICOS risk score validation: Newly diagnosed breast cancer undergoing treatment with anthracyclines analogues with or without radiotherapy, with or without trastuzumab, or other anticancer drugs

Exclusion Criteria

• Age <18 years old
• Not able to give informed consent
• Life expectancy <1 year
• Advanced-stage cancer not eligible for treatment (subjects with an indication of palliative care) according to treating physician's

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All causes mortality	For approximately a median of 3 years	Occurrence of all cause death
Cardiovascular mortality	For approximately a median of 3 years	Occurrence of cardiovascular mortality
Cancer therapy-related cardiovascular toxicity	For approximately a median of 3 years	Occurrence of cancer therapy-related cardiovascular toxicity

Trial Locations

Locations (5)

University of Bologna; 🇮🇹 Bologna, Italy

Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"; 🇮🇹 Palermo, Italy

Ss. Cyril and Methodius University in Skopje, University Clinic; 🇲🇰 Skopje, North Macedonia

University of Belgrade, Clinical Center of Serbia; 🇷🇸 Belgrade, Serbia

University of Belgrade, Clinical Hospital Center Bezanijska kosa; 🇷🇸 Belgrade, Serbia