Detection and Prevention of Cancer-Related Cardiovascular Toxicity Registry

Study Overview
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Brief Summary
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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

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

Conditions
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Cancer Related Cardiovascular Toxicity

Intervention / Treatment
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* Combination Product: 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast cancer<br>Newly diagnosed breast cancer undergoing treatment with anthracyclines analogues with or without radiotherapy, with or without trastuzumab, or other anticancer drugs. (Non-interventional prospective patient registry) | Combination Product: 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<br>* Follow-up visits at baseline, 3-months, and 1-year<br>* Other names: Non-interventional patient registry;|
| Female and Male<br>Diagnosis of cancer scheduled for treatment according to the treating physician's discretion. (Non-interventional patient registry) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All causes mortality | Occurrence of all cause death | For approximately a median of 3 years | 
| Cardiovascular mortality | Occurrence of cardiovascular mortality | For approximately a median of 3 years | 
| Cancer therapy-related cardiovascular toxicity | Occurrence of cancer therapy-related cardiovascular toxicity | For approximately a median of 3 years |