Registry to detect and prevent cancer-related heart damage
Official title: Detection and Prevention of Cancer-Related Cardiovascular Toxicity Registry (ISACS CARDIONCO-PREDICT)
Run by University of Bologna · NCT06086132 · Data updated 2026-11-12
This registry tries to track heart problems caused by cancer treatments and validate a risk score in adults with cancer, focusing on newly diagnosed breast cancer patients receiving anthracyclines.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 10000 (estimated) |
| Sponsor | University of Bologna Academic / other |
| Drugs / interventions | trastuzumab, chemotherapy |
| Locations | 5 sites (Bologna and 4 other locations) |
| Status | Recruiting |
| Started | May 1, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | June 19, 2025 |
| Trial ID | NCT06086132 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with a cancer diagnosis who can give informed consent and have life expectancy >1 year, especially newly diagnosed breast cancer patients starting anthracycline-based therapy, are ideal candidates.
✕Probably not a fit
Patients with advanced-stage disease receiving only palliative care, those with life expectancy <1 year, and those under 18 are unlikely to benefit from the registry’s risk-prediction results.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter observational registry will collect clinical and treatment data to document cardiovascular events linked to chemotherapy and radiotherapy and to identify predictors of cardiac toxicity. A predefined subset of newly diagnosed breast cancer patients treated with anthracycline analogues (with or without radiotherapy and with or without trastuzumab) will undergo prospective validation of the HFA‑ICOS risk score. Participating centers include the University of Bologna, Policlinico Paolo Giaccone Palermo, and Ss. Cyril and Methodius University Clinic in Skopje. Eligible adults must be able to consent and have an expected life expectancy greater than one year, while patients receiving only palliative care are excluded.
Why it matters
Potential benefit: If successful, the registry could help clinicians identify patients at higher risk for treatment-related heart damage and guide earlier monitoring or preventive measures to reduce cardiac complications.
How similar studies have gone: Previous retrospective analyses and smaller prospective cohorts of scores like HFA‑ICOS have shown promise, but large prospective multicenter validation is still limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
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 -
University of Bologna
Bologna, Italy Not yet recruiting -
Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"
Palermo, Italy Not yet recruiting
Study contacts
- Principal investigator: Prof. Olivia Manfrini, MD — University of Bologna
- Study coordinator: Edina Cenko
- Email: dimec.epicardio@unibo.it
- Phone: +3905121444911
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.