Clinical trial NCT06086132: Detection and Prevention of Cancer-Related Cardiovascular Toxicity Registry
Official title: Detection and Prevention of Cancer-Related Cardiovascular Toxicity Registry (ISACS CARDIONCO-PREDICT)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cancer Related Cardiovascular Toxicity
Lead sponsor: University of Bologna
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
First posted: 2023-10-17
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Confirmed diagnosis of cancer undergoing treatment

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


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

Primary outcomes:
measure: All causes mortality
timeFrame: For approximately a median of 3 years
measure: Cardiovascular mortality
timeFrame: For approximately a median of 3 years
measure: Cancer therapy-related cardiovascular toxicity
timeFrame: For approximately a median of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: University of Bologna
city: Palermo
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"
city: Skopje
country: North Macedonia
facility: Ss. Cyril and Methodius University in Skopje, University Clinic
city: Belgrade
country: Serbia
facility: University of Belgrade, Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: University of Belgrade, Clinical Hospital Center Bezanijska kosa
Study officials:
affiliation: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
name: Prof. Giuseppina Novo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bologna
name: Prof. Olivia Manfrini, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.