Detection and Prevention of Cancer-Related Cardiovascular Toxicity Registry

NCT ID: NCT06086132

Last Updated: 2025-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-01

Study Completion Date

2026-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Cancer Related Cardiovascular Toxicity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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)

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

Intervention Type COMBINATION_PRODUCT

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

Female and Male

Diagnosis of cancer scheduled for treatment according to the treating physician's discretion.

(Non-interventional patient registry)

No interventions assigned to this group

Interventions

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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

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Non-interventional patient registry

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

OTHER

Sponsor Role collaborator

University of Bologna

OTHER

Sponsor Role lead

Responsible Party

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Olivia Manfrini, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Prof. Olivia Manfrini, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bologna

Prof. Giuseppina Novo, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Locations

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University of Bologna

Bologna, , Italy

Site Status NOT_YET_RECRUITING

Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"

Palermo, , Italy

Site Status NOT_YET_RECRUITING

Ss. Cyril and Methodius University in Skopje, University Clinic

Skopje, , North Macedonia

Site Status RECRUITING

University of Belgrade, Clinical Center of Serbia

Belgrade, , Serbia

Site Status RECRUITING

University of Belgrade, Clinical Hospital Center Bezanijska kosa

Belgrade, , Serbia

Site Status RECRUITING

Countries

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Italy North Macedonia Serbia

Central Contacts

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Edina Cenko

Role: CONTACT

+3905121444911

Maria Bergami

Role: CONTACT

+3905121444911

References

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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.

Reference Type BACKGROUND
PMID: 36017568 (View on PubMed)

Other Identifiers

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ISACS CARDIONCO-PREDICT

Identifier Type: -

Identifier Source: org_study_id

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