Breast CancerRadioTherapyNCT05775822
Coronary Artery Calcium and Cardiovascular Risk Factors Analysis After RT or Breast Cancer
A study testing CT scan and blood sample collection in people with Breast Cancer, run by Centro Cardiologico Monzino at 1 site in Italy.
Trial summary
This is a no-profit, national, monocenter, retrospective, and prospective low-intervention study. It is a low-intervention study in terms of diagnostic additional procedure (CT scan). Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- CT scan and blood sample collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteItaly
- Study dates
- 24 Mar 2022to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women diagnosed with early-stage breast cancer treated with adjuvant whole breast external beam radiotherapy from 2010 to 2017;
- Patients with a > 5 years clinical follow-up (FU) from diagnosis of breast cancer
- Adult women/patients ≥18 years old and ≤ 60 years at time of radiation therapy;
- Patients with homogeneous and standardized radiation exposure protocol (external beam radiotherapy 40 Gy in 15 fractions)
- Patients who have signed the written informed consent
Who cannot join
- Patients aged < 18 or > 60 years at time of radiation therapy;
- Patients with bilateral breast cancer or breast cancer of unknown laterality;
- Patients with a prior diagnosis of invasive cancer (apart from non-melanoma skin cancer);
- Patients with known active ischemic heart disease during or before the RT period;
- Patients with no definitive surgery (e.g. a biopsy only);
- Patients who did not receive radiotherapy were excluded from the Study.
Show all 9Show fewer
- Patients who are currently participating in an investigational interventional study.
- IORT (Intraoperative radiotherapy) and PBI (partial breast radiotherapy) excluded
- Participants not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to Study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Coronary Artery Calcium and Cardiovascular Risk Factors Analysis After RT for Breast Cancer. A Gender-based Preventive Medicine Approach
This is a no-profit, national, monocenter, retrospective, and prospective low-intervention study. It is a low-intervention study in terms of diagnostic additional procedure (CT scan). It is planned to recruit a maximum of 100 women diagnosed with early-stage breast cancer and treated with adjuvant breast radiotherapy from 2010 to 2017 at the European Institute of Oncology who meet all the inclusion and exclusion criteria. The aim of the Study is to analyze a population of breast cancer patients treated by adjuvant whole breast radiotherapy to identify the most important cardiovascular (CV) risk factors linked to coronary artery disease (CAD) development, in a cure-without-complications oncology strategy.
Read the detailed description
In the present study a pre-screening activity is planned, that will be conducted by the European Institute of Oncology (IEO) at the Division of Radiotherapy. It will be done to identify and select from the IEO's database about 100 women diagnosed with early-stage breast cancer and treated with adjuvant breast radiotherapy, from 2010 to 2017, and with a > 5 years clinical Follow up (FU). All patients, who present pre-specified RT treatment, in terms of radiation exposure, and radiation protocol (IORT excluded as well as previous RT treatments), will be proposed to participate in the Study. The researcher of the IEO will contact by phone each identified patient (eligible patients) to request her interest in participating in the present study and to obtain her availability to be contacted by the Investigator of Centro Cardiologico Monzino (CCM) to define all aspects and activities planned in the protocol.
Patients who meet all eligibility criteria, after signing the informed consent form, at Centro Cardioogico Monzino, will be enrolled in the study. After execution of the CT scan the patient will be contacted to discuss the CT scan result. In case of high calcium score values, patients will be performing a cardiological medical examination, ECG, and further diagnostic investigations, as clinically indicated.
- Conditions
- Breast Cancer
- Being tested
- CT scan and blood sample collection
- Keywords
- Breast cancer, Coronary Artery Disease, Calcium Score, Radiotherapy, Cardiovascular events, CV risk factors, Cardio-oncology
- Medical subject headings
- Breast Neoplasms, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scan and blood sample collectionDiagnostic test
Each enrolled patient performs:
- preventive clinical cardiology assessment visit, addressed to individualized risk profile assessment and addressed to chest CT scan.
- a blood sampling (1 citrate tube of 5 ml) will be done the same day just the chest CT scan and analyzed locally also for future research of biomarker discovery (single sample, for those patients who agree in ICF)
- CT scan
| Study group | Role | What they receive |
|---|---|---|
| Single arm study | Other | After signing the informed consent form, patients who meet all eligibility criteria will be enrolled in the Study. After execution of the CT scan the patient will be contacted to discuss the CT scan result. In case of high calcium score values, patients will be performing a cardiological medical examination, ECG, and further diagnostic investigations, as clinically indicated Receives: Diagnostic Test: CT scan and blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Coronary calcium (CAC)
Coronary calcium (CAC) assessment and its relationship with left-side or right-side breast radiation therapy and previously known cardiovascular risk factors. The quantification of CAC will be performed according to the Agatston score by multiplying the total CAC area in mm2 by a density factor ranging from 1 to 4 (1 for lesions with a density of 130-199 HU; 2 if the lesion has a density of 200-299 HU; 3 for lesions with a density of 300-399 HU; 4 for densities ≥400 HU)
Measured: 2 years
Secondary outcomes (2)
Outcome 2 circulating markers
Evaluate circulating markers, mostly related to radiation-induced oxidative stress and correlate them to previous CV events and CT data obtained. Patients will undergo a blood sample withdrawal focused on evaluation of albumin isoforms in human plasma and protein signatures.
Albumin thiolation: Mercaptoalbumin (HSA-SH) and thiolated albumin (+120 ± 2 Da, Thio-HSA) will be detected and their intensities used to calculate the relative abundances. Targeted Proteomics will be performed and relative quantitation will be expressed in Normalized protein expression (NPX), Normalized Protein eXpression, is Olink's arbitrary unit which is in Log2 scale. It is calculated from Ct values and data pre-processing (normalization) is performed to minimize both intra- and inter-assay variation. NPX data allows users to identify changes for individual protein levels across their sample set, and then use this data to establish protein signatures.
Measured: 2 years
Outcome 3 Incidence of CV events
Incidence of CV events in relationship to left vs right-side breast radiation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start24 Mar 2022
- Primary completion20 Dec 2023
- Study completion31 Jan 2024
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 Breast CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Europeo di Oncologia
- Responsible party
- Sponsor
- Investigators
- Daniela Trabattoni, MD, Principal investigator, IRCCS Centro Cardiologico Monzino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775822
- Sponsor's protocol ID
- CCM 1505
- Acronym
- RadioTherapy
- Status last verified
- Mar 2023
- First submitted
- 17 Feb 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Trabattoni D, Leonardi MC, Mancini ME, Jereczek-Fossa BA, Cattani F, Santagostino Baldi G, Bonomi A, Galotta A, Mushtaq S, Annoni A, Alio D, Vincini MG, Fodor CI, La Grutta L, Montorsi P, Pontone G. Coronary artery calcium and cardiovascular risk factors analysis after radiotherapy for breast cancer (the CLARIFIER: a gender-based preventive medicine study). Front Cardiovasc Med. 2025 Aug 4;12:1615793. doi: 10.3389/fcvm.2025.1615793. eCollection 2025.
PubMed 40832141
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Artery Calcium and Cardiovascular Risk Factors Analysis After RT for Breast Cancer. A Gender-based Preventive Medicine Approach
- ClinicalTrials.gov ID
- NCT05775822
- Acronym / sponsor ID
- RadioTherapy / CCM 1505
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Coronary Artery Disease, Calcium Score, Radiotherapy, Cardiovascular events, CV risk factors, Cardio-oncology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Collaborators
- Istituto Europeo di Oncologia
- Study start
- 24 Mar 2022 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 20 Mar 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 is a no-profit, national, monocenter, retrospective, and prospective low-intervention study. It is a low-intervention study in terms of diagnostic additional procedure (CT scan). It is planned to recruit a maximum of 100 women diagnosed with early-stage breast cancer and treated with adjuvant breast radiotherapy from 2010 to 2017 at the European Institute of Oncology who meet all the inclusion and exclusion criteria. The aim of the Study is to analyze a population of breast cancer patients treated by adjuvant whole breast radiotherapy to identify the most important cardiovascular (CV) risk factors linked to coronary artery disease (CAD) development, in a cure-without-complications oncology strategy.
Detailed description
In the present study a pre-screening activity is planned, that will be conducted by the European Institute of Oncology (IEO) at the Division of Radiotherapy. It will be done to identify and select from the IEO's database about 100 women diagnosed with early-stage breast cancer and treated with adjuvant breast radiotherapy, from 2010 to 2017, and with a > 5 years clinical Follow up (FU). All patients, who present pre-specified RT treatment, in terms of radiation exposure, and radiation protocol (IORT excluded as well as previous RT treatments), will be proposed to participate in the Study. The researcher of the IEO will contact by phone each identified patient (eligible patients) to request her interest in participating in the present study and to obtain her availability to be contacted by the Investigator of Centro Cardiologico Monzino (CCM) to define all aspects and activities planned in the protocol.
Patients who meet all eligibility criteria, after signing the informed consent form, at Centro Cardioogico Monzino, will be enrolled in the study. After execution of the CT scan the patient will be contacted to discuss the CT scan result. In case of high calcium score values, patients will be performing a cardiological medical examination, ECG, and further diagnostic investigations, as clinically indicated.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm study | Other | Diagnostic Test: CT scan and blood sample collectionAfter signing the informed consent form, patients who meet all eligibility criteria will be enrolled in the Study. After execution of the CT scan the patient will be contacted to discuss the CT scan result. In case of high calcium score values, patients will be performing a cardiological medical examination, ECG, and further diagnostic investigations, as clinically indicated |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women diagnosed with early-stage breast cancer treated with adjuvant whole breast external beam radiotherapy from 2010 to 2017;
- Patients with a > 5 years clinical follow-up (FU) from diagnosis of breast cancer
- Adult women/patients ≥18 years old and ≤ 60 years at time of radiation therapy;
- Patients with homogeneous and standardized radiation exposure protocol (external beam radiotherapy 40 Gy in 15 fractions)
- Patients who have signed the written informed consent
Key exclusion criteria (9 listed)
- Patients aged < 18 or > 60 years at time of radiation therapy;
- Patients with bilateral breast cancer or breast cancer of unknown laterality;
- Patients with a prior diagnosis of invasive cancer (apart from non-melanoma skin cancer);
- Patients with known active ischemic heart disease during or before the RT period;
- Patients with no definitive surgery (e.g. a biopsy only);
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 |
|---|---|---|
| CT scan and blood sample collectionEach enrolled patient performs: * preventive clinical cardiology assessment visit, addressed to individualized risk profile assessment and addressed to chest CT scan. * a blood sampling (1 citrate tube of 5 ml) will be done the same day just the chest CT scan and analyzed locally also for future research of biomarker discovery (single sample, for those patients who agree in ICF) * CT scan | Diagnostic test | Single arm study |
Primary outcome
Primary Outcome Coronary calcium (CAC)
Time frame: 2 years
Coronary calcium (CAC) assessment and its relationship with left-side or right-side breast radiation therapy and previously known cardiovascular risk factors. The quantification of CAC will be performed according to the Agatston score by multiplying the total CAC area in mm2 by a density factor ranging from 1 to 4 (1 for lesions with a density of 130-199 HU; 2 if the lesion has a density of 200-299 HU; 3 for lesions with a density of 300-399 HU; 4 for densities ≥400 HU)
2 secondary outcomes
Outcome 2 circulating markers
Time frame: 2 years
Outcome 3 Incidence of CV events
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Derived from this study: PubMed 40832141Trabattoni D, Leonardi MC, Mancini ME, Jereczek-Fossa BA, Cattani F, Santagostino Baldi G, Bonomi A, Galotta A, Mushtaq S, Annoni A, Alio D, Vincini MG, Fodor CI, La Grutta L, Montorsi P, Pontone G. Coronary artery calcium and cardiovascular risk factors analysis after radiotherapy for breast cancer (the CLARIFIER: a gender-based preventive medicine study). Front Cardiovasc Med. 2025 Aug 4;12:1615793. doi: 10.3389/fcvm.2025.1615793. eCollection 2025.
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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. This study is not recruiting at the moment.
Daniela Trabattoni, MD principal investigator
IRCCS Centro Cardiologico Monzino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT scan and blood sample collection in people with Breast Cancer, run by Centro Cardiologico Monzino at 1 site in Italy.
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 9 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: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Coronary calcium (CAC) (time frame: 2 years). 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 NCT05775822, 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 7 Feb 2024.