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Detection and Prevention of Cancer-Related Cardiovascular Toxicity Registry

Not yet recruiting
Conditions
Cancer Related Cardiovascular Toxicity
Interventions
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
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

Recruitment & Eligibility

Status
NOT_YET_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
Arm && Interventions
GroupInterventionDescription
Breast cancerProspective 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 radiotherapyNewly 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)
Primary Outcome Measures
NameTimeMethod
All causes mortalityFor approximately a median of 3 years

Occurrence of all cause death

Cardiovascular mortalityFor approximately a median of 3 years

Occurrence of cardiovascular mortality

Cancer therapy-related cardiovascular toxicityFor approximately a median of 3 years

Occurrence of cancer therapy-related cardiovascular toxicity

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (5)

University of Bologna

🇮🇹

Bologna, Italy

Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"

🇮🇹

Palermo, Italy

University of Belgrade, Clinical Hospital Center Bezanijska kosa

🇷🇸

Belgrade, Serbia

University of Belgrade, Clinical Center of Serbia

🇷🇸

Belgrade, Serbia

Ss. Cyril and Methodius University in Skopje, University Clinic

🇲🇰

Skopje, North Macedonia

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