Cancer Related Cardiovascular ToxicityNCT06086132
Detection and Prevention of Cancer-Related Cardiovascular Toxicity Registry
An observational study of Cancer Related Cardiovascular Toxicity, run by University of Bologna at 5 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Related Cardiovascular Toxicity
- What is being tested?
- 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
- How many people
- 10,000 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 1 May 2025to 31 Dec 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Confirmed diagnosis of cancer undergoing treatment
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 3 countries
Italy2 sites, 2 recruiting
- Not yet recruiting
University of Bologna
Bologna
- Not yet recruiting
Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"
Palermo
Serbia2 sites, 2 recruiting
- Recruiting
University of Belgrade, Clinical Center of Serbia
Belgrade
- Recruiting
University of Belgrade, Clinical Hospital Center Bezanijska kosa
Belgrade
North Macedonia1 site, 1 recruiting
- Recruiting
Ss. Cyril and Methodius University in Skopje, University Clinic
Skopje
About this study
Official title: Detection and Prevention of Cancer-Related Cardiovascular Toxicity Registry (ISACS CARDIONCO-PREDICT)
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
- Being tested
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 radiotherapyCombination product
Also called Non-interventional patient registry
Follow-up visits at baseline, 3-months, and 1-year
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
All causes mortality
Occurrence of all cause death
Measured: For approximately a median of 3 years
Cardiovascular mortality
Occurrence of cardiovascular mortality
Measured: For approximately a median of 3 years
Cancer therapy-related cardiovascular toxicity
Occurrence of cancer therapy-related cardiovascular toxicity
Measured: For approximately a median of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start1 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer Related Cardiovascular ToxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
- Responsible party
- Principal investigator, Olivia Manfrini, MD, University of Bologna
- Investigators
- Prof. Olivia Manfrini, MD, Principal investigator, University of BolognaProf. Giuseppina Novo, MD, Principal investigator, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06086132
- Sponsor's protocol ID
- ISACS CARDIONCO-PREDICT
- Status last verified
- Jun 2025
- First submitted
- 11 Oct 2023
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 36017568
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection and Prevention of Cancer-Related Cardiovascular Toxicity Registry (ISACS CARDIONCO-PREDICT)
- ClinicalTrials.gov ID
- NCT06086132
- Acronym / sponsor ID
- ISACS CARDIONCO-PREDICT
- Conditions
- Cancer Related Cardiovascular Toxicity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast cancer | – | 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 radiotherapyNewly 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) |
| Female and Male | – | –Diagnosis of cancer scheduled for treatment according to the treating physician's discretion. (Non-interventional patient registry) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Confirmed diagnosis of cancer undergoing treatment
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 radiotherapyAlso: Non-interventional patient registryFollow-up visits at baseline, 3-months, and 1-year | Combination product | Breast cancer |
Primary outcome
All causes mortality
Time frame: For approximately a median of 3 years
Occurrence of all cause death
Cardiovascular mortality
Time frame: For approximately a median of 3 years
Occurrence of cardiovascular mortality
Cancer therapy-related cardiovascular toxicity
Time frame: For approximately a median of 3 years
Occurrence of cancer therapy-related cardiovascular toxicity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Background: PubMed 36017568Lyon 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prof. Olivia Manfrini, MD principal investigator
University of Bologna
Prof. Giuseppina Novo, MD principal investigator
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Related Cardiovascular Toxicity, run by University of Bologna at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy, Serbia, North Macedonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edina Cenko (+3905121444911, dimec.epicardio@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All causes mortality (time frame: For approximately a median of 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06086132, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.