Coronary Artery Calcium and Cardiovascular Risk Factors Analysis After RT for Breast Cancer. A Gender-based Preventive Medicine Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Primary Outcome Coronary calcium (CAC)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Primary Outcome Coronary calcium (CAC)
时间窗: 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)
次要结局
- Outcome 2 circulating markers(2 years)
- Outcome 3 Incidence of CV events(2 years)