Global Cardio Oncology Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 2
- 主要终点
- New cardiovascular events
研究概览
简要总结
G-COR is the first Global Prospective Cardio-Oncology Registry. It is a multinational, multicenter prospective observational cohort registry, with the goal of collecting clinical, laboratory, imaging, demographic, and socioeconomic data to identify risk factors associated with increased incidence of cancer therapy related cardiovascular toxicity (CTR-CVT) in different settings and to derive and validate risk scores for cardio oncology patients treated in different geographic locations throughout the world.
详细描述
G-COR is the first Global Prospective Cardio-Oncology Registry. It is a multinational, multicenter prospective observational cohort registry, with the goal of collecting clinical, laboratory, imaging, demographic, and socioeconomic data to identify risk factors associated with increased incidence of cancer therapy related cardiovascular toxicity (CTR-CVT) in different settings and to derive and validate risk scores for cardio oncology patients treated in different geographic locations throughout the world.
G-COR will involve the collaboration from 124 hospitals from 24 countries that completed survey with sites demographics. It will evaluate cardiovascular disease in three distinct populations of cancer patients (hematological malignancies: lymphomas, leukemias, multiple myeloma; breast cancer patients; and patients treated with check point inhibitors immunotherapy).
G-COR will evaluate the cardiovascular impact of different cancer treatments in the above-described patients, and similarities and differences in diagnostic and treatment modalities as well as outcomes and the impact of socioeconomic factors and risk factors for toxicities in a large worldwide population.
G-COR will study the impact of cancer in CV disease in cancer patients treated at academic centers as well as in patients treated at community hospitals, through a systematic prospective data collection in a global digital platform.
G-COR is an IRB approved prospective registry, conducted with the logistical support of C5 Clinical Research Division and the Cardiovascular Outcomes Registries and Research (CORR) group at the Cleveland Clinic and have developed eCRFs with an extensive Red Cap Cloud platform.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New cardio-oncology consultation for breast cancer patients, or
- •New cardio-oncology consultation for Hodgkin's or non-Hodgkin's lymphoma patients, or
- •New cardio-oncology consultation for acute or chronic leukemia patients, or
- •New cardio-oncology consultation for multiple myeloma or AL amyloidosis, or
- •New cardio-oncology consultations for immune check-point inhibitors cardiac evaluation.
- •All patients have to be 18 years old or older
排除标准
- •Cardio-oncology patients who have previously had cardio-oncology evaluation and follow up by the investigators.
- •Minors less than 18 years old.
- •Inability or unwillingness to consent to participate
结局指标
主要结局
New cardiovascular events
时间窗: 18 months of prospective follow up
Heart failure, myocardial infarction, cardiac arrhythmias, syncope, coronary revascularization, heart transplant, cerebrovascular accident, peripheral arterial disease, hypertension, pulmonary hypertension. All events will be adjudicated according to standard clinical definitions.
Cardiotoxicity
时间窗: 18 months of prospective follow up
Any new cardiac event occurring during or after cancer treatment
Cardiovascular death.
时间窗: 18 months of prospective follow up
Death during or after cancer treatment, adjudicated to cardiovascular causes by treating physicians.
次要结局
未报告次要终点
研究者
Sadler,Diego MD
MD FACC Associate Professor of Medicine. CCLCM CWRU
The Cleveland Clinic
