Studies

Observational Not yet recruiting

NCT06086132 on ClinicalTrials.gov

Detection and Prevention of Cancer-Related Cardiovascular Toxicity Registry

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

  • Sponsor: University of Bologna
  • Collaborators: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
  • Enrollment: 10000 (Estimated)
  • Study start: 2025-06-01 (Estimated)
  • Primary completion: 2026-12-31 (Estimated)
  • Study completion: 2026-12-31 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

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

Conditions

  • Cancer Related Cardiovascular Toxicity

Intervention / Treatment

  • 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

Primary Outcome Measures

  • 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

Countries

Italy, North Macedonia, Serbia

Locations and Investigators

  • 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

Study Officials

  • Prof. Giuseppina Novo, MD (Principal Investigator) — Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
  • Prof. Olivia Manfrini, MD (Principal Investigator) — University of Bologna