Detection and Prevention of Cancer-Related Cardiovascular Toxicity Registry

Sponsor

University of Bologna (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06086132

Collaborator

University of Palermo (Other)

10,000

Enrollment

Locations

Anticipated Duration (Months)

2000

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Cancer Related Cardiovascular Toxicity	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

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

10000 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
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 Follow-up visits at baseline, 3-months, and 1-year Other Names: Non-interventional patient registry
Female and Male Diagnosis of cancer scheduled for treatment according to the treating physician's discretion. (Non-interventional patient registry)

Arm

Intervention/Treatment

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

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

Other Names:

Non-interventional patient registry

Female and Male

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

Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	University of Bologna	Bologna	Italy
2	University of Palermo	Palermo	Italy
3	Ss. Cyril and Methodius University in Skopje, University Clinic	Skopje	North Macedonia
4	University of Belgrade, Clinical Center of Serbia	Belgrade	Serbia
5	University of Belgrade, Clinical Hospital Center Bezanijska kosa	Belgrade	Serbia

Sponsors and Collaborators

University of Bologna
University of Palermo

Investigators

Principal Investigator: Prof. Giuseppina Novo, MD, University of Palermo
Principal Investigator: Prof. Olivia Manfrini, MD, University of Bologna

Study Documents (Full-Text)

None provided.

More Information

Publications

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. Erratum In: Eur Heart J. 2023 May 7;44(18):1621.

Responsible Party:

Olivia Manfrini, Professor, University of Bologna

ClinicalTrials.gov Identifier:

NCT06086132

Other Study ID Numbers:

ISACS CARDIONCO-PREDICT

First Posted:

Oct 17, 2023

Last Update Posted:

Oct 17, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 17, 2023