Understanding CARdiac Events in Breast Cancer - Pilot Cardio-Oncology Assessment and Surveillance Pathway for Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- The number of participants with successful application of guideline-directed Cardio-Oncology assessments and surveillance.
研究概览
简要总结
In Ireland, over 3,000 patients are diagnosed with breast cancer annually, and 1 in 9 Irish women will be diagnosed with breast cancer in their lifetime. There is evidence that female breast cancer survivors are more likely to die of cardiovascular disease than their age-matched counterparts.
This research is focused on evaluating pathways for identifying, managing, and overcoming side effects of cancer therapies that can negatively impact quality-of-life and overall outcomes for women during and after cancer treatment. The Cardio-oncology research team at GUH plan to capitalize on their expertise in both cancer care and cardiology to develop a care pathway for cancer patients who are at increased risk of developing heart disease.
详细描述
Establishment of a Cardio-Oncology assessment and surveillance pathway for breast cancer patients undergoing adjuvant systemic chemotherapy at GUH and the assessment of the feasibility of trialing this approach for risk assessment and early detection of CTRCD in a multicenter, prospective RCT which will inform future development of clinical services for cancer patients nationally and later internationally.
Study Design:
This study is a prospective, single arm, pilot feasibility study.
Study Population:
The study will focus on adult female patients diagnosed with stage I-III breast cancer (BC).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged ≥ 18 years
- •Ability to read and understand English
- •Breast Cancer Stage I- III planned to receive systemic chemotherapy
排除标准
- •Patients not for systemic chemotherapy with curative intent
- •Patients who are unable to co-operate with the study protocol
- •Patients who are unable to give informed consent
结局指标
主要结局
The number of participants with successful application of guideline-directed Cardio-Oncology assessments and surveillance.
时间窗: 2 years
To calculate the percentage of patients who successfully completed all guideline required investigations for baseline assessments, during and post chemotherapy surveillance i.e. Echocardiography, ECG, and Cardiac biomarkers (troponin and BNP).
次要结局
- The number of participants with cardiovascular disease (CVD) among patients with breast cancer prior to commencement of systemic chemotherapy.(Baseline)
- The number of participants with successful collection and biobanking specimens among patients with breast cancer undergoing systemic chemotherapy.(Baseline, 3M, 6M, 9M, 12M, 24M)
- The number of participants with successful collection of guideline-required imaging data among patients with breast cancer undergoing systemic chemotherapy.(Baseline, 3M, 6M, 9M, 12M, 24M)
- The number of participants with successful collection of guideline-required clinical data among patients with breast cancer undergoing systemic chemotherapy.(Baseline, 3M, 6M, 9M, 12M, 24M)
- The number of participants with common risk factors for CTRCD among patients with breast cancer prior to commencement of systemic chemotherapy.(Baseline)
- Incidence of CTRCD in Irish breast cancer patients receiving chemotherapy.(3M, 6M, 9M, 12M, 24M)
研究者
Professor Osama SOLIMAN
Professor of Cardiovascular Research
National University of Ireland, Galway, Ireland