Detection and Prevention of Cancer-Related Cardiovascular Toxicity Registry
June 16, 2025 updated by: Olivia Manfrini, MD, University of Bologna
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
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
10000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Edina Cenko
- Phone Number: +3905121444911
- Email: dimec.epicardio@unibo.it
Study Contact Backup
- Name: Maria Bergami
- Phone Number: +3905121444911
- Email: dimec.epicardio@unibo.it
Study Locations
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-
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Bologna, Italy
- Not yet recruiting
- University of Bologna
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Palermo, Italy
- Not yet recruiting
- Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"
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-
-
-
-
Skopje, North Macedonia
- Recruiting
- Ss. Cyril and Methodius University in Skopje, University Clinic
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-
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Belgrade, Serbia
- Recruiting
- University of Belgrade, Clinical Center of Serbia
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Belgrade, Serbia
- Recruiting
- University of Belgrade, Clinical Hospital Center Bezanijska kosa
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Confirmed diagnosis of cancer undergoing treatment
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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) |
Follow-up visits at baseline, 3-months, and 1-year
Other Names:
|
|
Female and Male
Diagnosis of cancer scheduled for treatment according to the treating physician's discretion. (Non-interventional patient registry) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
All causes mortality
Time Frame: For approximately a median of 3 years
|
Occurrence of all cause death
|
For approximately a median of 3 years
|
|
Cardiovascular mortality
Time Frame: For approximately a median of 3 years
|
Occurrence of cardiovascular mortality
|
For approximately a median of 3 years
|
|
Cancer therapy-related cardiovascular toxicity
Time Frame: For approximately a median of 3 years
|
Occurrence of cancer therapy-related cardiovascular toxicity
|
For approximately a median of 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Prof. Olivia Manfrini, MD, University of Bologna
- Principal Investigator: Prof. Giuseppina Novo, MD, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
October 11, 2023
First Submitted That Met QC Criteria
October 11, 2023
First Posted (Actual)
October 17, 2023
Study Record Updates
Last Update Posted (Actual)
June 19, 2025
Last Update Submitted That Met QC Criteria
June 16, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- ISACS CARDIONCO-PREDICT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.