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Clinical Trials/NCT06086132
NCT06086132
Recruiting
Not Applicable

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

University of Bologna5 sites in 3 countries10,000 target enrollmentMay 1, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer Related Cardiovascular Toxicity
Sponsor
University of Bologna
Enrollment
10000
Locations
5
Primary Endpoint
All causes mortality
Status
Recruiting
Last Updated
10 months ago

Overview

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

Registry
clinicaltrials.gov
Start Date
May 1, 2025
End Date
December 31, 2026
Last Updated
10 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Bologna
Responsible Party
Principal Investigator
Principal Investigator

Olivia Manfrini, MD

Professor

University of Bologna

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

Outcomes

Primary Outcomes

All causes mortality

Time Frame: For approximately a median of 3 years

Occurrence of all cause death

Cardiovascular mortality

Time Frame: For approximately a median of 3 years

Occurrence of cardiovascular mortality

Cancer therapy-related cardiovascular toxicity

Time Frame: For approximately a median of 3 years

Occurrence of cancer therapy-related cardiovascular toxicity

Study Sites (5)

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