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Trial Title:
Detection and Prevention of Cancer-Related Cardiovascular Toxicity Registry
NCT ID:
NCT06086132
Condition:
Cancer Related Cardiovascular Toxicity
Study type:
Observational [Patient Registry]
Overall status:
Not yet recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Combination Product
Intervention name:
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
Description:
Follow-up visits at baseline, 3-months, and 1-year
Arm group label:
Breast cancer
Other name:
Non-interventional patient registry
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
Criteria for eligibility:
Study pop:
Confirmed diagnosis of cancer undergoing treatment
Sampling method:
Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Bologna
Address:
City:
Bologna
Country:
Italy
Facility:
Name:
Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"
Address:
City:
Palermo
Country:
Italy
Facility:
Name:
Ss. Cyril and Methodius University in Skopje, University Clinic
Address:
City:
Skopje
Country:
North Macedonia
Facility:
Name:
University of Belgrade, Clinical Center of Serbia
Address:
City:
Belgrade
Country:
Serbia
Facility:
Name:
University of Belgrade, Clinical Hospital Center Bezanijska kosa
Address:
City:
Belgrade
Country:
Serbia
Start date:
July 1, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
University of Bologna
Agency class:
Other
Collaborator:
Agency:
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Agency class:
Other
Source:
University of Bologna
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06086132
