Back to resultsCoronary Artery Calcium and Cardiovascular Risk Factors Analysis After RT or Breast Cancer (RadioTherapy)
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
CT scan and blood sample collection
Sponsored by
About this trial
This is an interventional screening trial for Breast Cancer focused on measuring Breast cancer, Coronary Artery Disease, Calcium Score, Radiotherapy, Cardiovascular events, CV risk factors, Cardio-oncology
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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. 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
Sites / Locations
- IRCCS Centro Cardiologico MonzinoRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single arm study
Arm Description
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
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
Outcome 3 Incidence of CV events
Incidence of CV events in relationship to left vs right-side breast radiation
Full Information
NCT ID
NCT05775822
First Posted
February 17, 2023
Last Updated
March 17, 2023
Sponsor
Centro Cardiologico Monzino
Collaborators
Istituto Europeo di Oncologia
1. Study Identification
Unique Protocol Identification Number
NCT05775822
Brief Title
Coronary Artery Calcium and Cardiovascular Risk Factors Analysis After RT or Breast Cancer
Acronym
RadioTherapy
Official Title
Coronary Artery Calcium and Cardiovascular Risk Factors Analysis After RT for Breast Cancer. A Gender-based Preventive Medicine Approach
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 24, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centro Cardiologico Monzino
Collaborators
Istituto Europeo di Oncologia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, Coronary Artery Disease, Calcium Score, Radiotherapy, Cardiovascular events, CV risk factors, Cardio-oncology
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single arm study
Arm Type
Other
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
CT scan and blood sample collection
Intervention Description
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
Primary Outcome Measure Information:
Title
Primary Outcome Coronary calcium (CAC)
Description
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)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Outcome 2 circulating markers
Description
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.
Time Frame
2 years
Title
Outcome 3 Incidence of CV events
Description
Incidence of CV events in relationship to left vs right-side breast radiation
Time Frame
2 years
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women diagnosed with early-stage breast cancer and treated with adjuvant breast radiotherapy from 2010 to 2017 at European Institute of Oncology
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniela Trabattoni, MD
Phone
02.58002780
Email
daniela.trabattoni@cardiologicomonzino.it
First Name & Middle Initial & Last Name or Official Title & Degree
Gianluca Pontone, MD, PhD
Phone
02.58002574
Email
gianluca.pontone@cardiologicomonzino.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela Trabattoni, MD
Organizational Affiliation
IRCCS Centro Cardiologico Monzino
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Centro Cardiologico Monzino
City
Milan
ZIP/Postal Code
20138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Trabattoni, MD
Phone
02.58002546
Email
daniela.trabattoni@cardiologicomonzino.it
First Name & Middle Initial & Last Name & Degree
Gianluca Pontone, MD, PhD
Phone
02.58002574
Email
gianluca.pontone@cardiologicomonzino.it
12. IPD Sharing Statement
Learn more about this trial
Coronary Artery Calcium and Cardiovascular Risk Factors Analysis After RT or Breast Cancer
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