Clinical trial

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

Name

ISACS CARDIONCO-PREDICT

Description

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

Trial arms

Trial start

2024-07-01

Estimated PCD

2025-12-31

Trial end

2025-12-31

Status

Not yet recruiting

Treatment

Prospective 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

Arms:

Breast cancer

Other names:

Non-interventional patient registry

Size

10000

Primary endpoint

All causes mortality

For approximately a median of 3 years

Cardiovascular mortality

For approximately a median of 3 years

Cancer therapy-related cardiovascular toxicity

For approximately a median of 3 years

Eligibility criteria

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '3 Years', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'count': 10000, 'type': 'ESTIMATED'}}

Updated at

2024-05-08

1 organization

1 product

1 indication

Organization

University of Bologna

Product

HFA-ICOS Risk Score

Indication

Cancer-related cardiovascular toxicity