Detection and Prevention of Cancer-Related Cardiovascular Toxicity Registry

Detection and Prevention of Cancer-Related Cardiovascular Toxicity Registry (ISACS CARDIONCO-PREDICT)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06086132

Enrollment

10000

Registered

2023-10-17

Start date

2025-05-01

Completion date

2026-12-31

Last updated

2025-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Related Cardiovascular Toxicity

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

Interventions

COMBINATION_PRODUCTProspective validation of the HFA-ICOS risk score in a subset of subjects with newly diagnosed breast cancer and undergoing treatment with anthracyclines analogues with or without radiotherapy

Follow-up visits at baseline, 3-months, and 1-year

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Cancer therapy-related cardiovascular toxicity	For approximately a median of 3 years	Occurrence of cancer therapy-related cardiovascular toxicity
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

Countries

Italy, North Macedonia, Serbia

Contacts

Primary ContactEdina Cenko

dimec.epicardio@unibo.it+3905121444911

Backup ContactMaria Bergami