Detection and Prevention of Cancer-Related Cardiovascular Toxicity Registry

NCT06086132 | Recruiting

• 1 other identifier: ISACS CARDIONCO-PREDICT
• Study Type: observational
• Target: 10,000
• Locations: 3 countries
• Sites: 5

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Breast cancer

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

Female and Male

Diagnosis of cancer scheduled for treatment according to the treating physician's discretion. (Non-interventional patient registry)

Interventions

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 COMBINATION_PRODUCT

Follow-up visits at baseline, 3-months, and 1-year

Also known as: Non-interventional patient registry

Breast cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Confirmed diagnosis of cancer undergoing treatment

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bologna: lead
• Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo: collaborator

Study Sites (5)

University of Bologna

Bologna, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"

Palermo, Italy

NOT YET RECRUITING

Ss. Cyril and Methodius University in Skopje, University Clinic

Skopje, North Macedonia

RECRUITING

University of Belgrade, Clinical Center of Serbia

Belgrade, Serbia

RECRUITING

University of Belgrade, Clinical Hospital Center Bezanijska kosa

Belgrade, Serbia

RECRUITING

Related Publications (1)

• Lyon AR, Lopez-Fernandez T, Couch LS, Asteggiano R, Aznar MC, Bergler-Klein J, Boriani G, Cardinale D, Cordoba R, Cosyns B, Cutter DJ, de Azambuja E, de Boer RA, Dent SF, Farmakis D, Gevaert SA, Gorog DA, Herrmann J, Lenihan D, Moslehi J, Moura B, Salinger SS, Stephens R, Suter TM, Szmit S, Tamargo J, Thavendiranathan P, Tocchetti CG, van der Meer P, van der Pal HJH; ESC Scientific Document Group. 2022 ESC Guidelines on cardio-oncology developed in collaboration with the European Hematology Association (EHA), the European Society for Therapeutic Radiology and Oncology (ESTRO) and the International Cardio-Oncology Society (IC-OS). Eur Heart J. 2022 Nov 1;43(41):4229-4361. doi: 10.1093/eurheartj/ehac244. No abstract available.

  PMID: 36017568 BACKGROUND

MeSH Terms

Interventions

Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Prof. Olivia Manfrini, MD

  University of Bologna

  PRINCIPAL INVESTIGATOR

• Prof. Giuseppina Novo, MD

  Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edina Cenko

CONTACT

+3905121444911; dimec.epicardio@unibo.it

Maria Bergami

CONTACT

+3905121444911; dimec.epicardio@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 17, 2023
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 19, 2025

Record last verified: 2025-06

Locations

IT (2); NO (1); SE (2)