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临床试验/NCT05598879
NCT05598879招募中不适用

Global Cardio Oncology Registry

The Cleveland Clinic2 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2022年7月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sadler,Diego MD

MD FACC Associate Professor of Medicine. CCLCM CWRU

The Cleveland Clinic

研究点 (2)

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