Cardiovascular Outcome of Cancer Patients: The "GMEDICO Cohort"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 530
- 试验地点
- 2
- 主要终点
- Dosage of cardiac biomarkers
研究概览
简要总结
The Mediterranean Group of Cardio-Oncology (GMEDICO) brings together French cardiologists and oncologists who have developed a protocol for the monitoring and cardio-oncological management of patients treated for cancer.
This unique organization makes it possible to envisage the creation of a large cohort from which the incidence and predictive factors of cardiovascular toxicity can be determined.
Primary objective: to determine the cardiovascular prognosis of patients treated for cancer and followed up in cardio-oncology.
Secondary objectives
- To determine the clinical, biological and imaging factors associated with cardiovascular events under cancer treatment, in order to define a risk score including clinical, biological (biomarker) and imaging data.
- To create a biological source for testing other biomarkers and conducting genome-wide association studies and genetic factors associated with cardiovascular events under cancer treatment.
详细描述
Each patient will be monitored for 5 years. Cardio-oncological follow-up and management within these centers will follow a common protocol established and validated in March 2016 on the basis of international recommendations and summaries of the characteristics produced for each drug. Additional blood samples will be taken for the biobanking. Depending on the case, a small skin biopsy will be carried out to analyze the cardiovascular response of in vitro immunotherapy using a reprogramming model of fibroblasts in hiPSC hiPSC (human induced Pluripotent Stem cells)-cardiomyocytes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •All adults referred for specialist cardio-oncology consultations before the initiation of a cancer treatment according to pre-established indications will be eligible.
排除标准
- •Failure to provide information that makes it impossible to complete a consultation form or refuse to sign the consent.
- •Minor or major patient under guardianship
- •Pregnant or breastfeeding woman
结局指标
主要结局
Dosage of cardiac biomarkers
时间窗: 5 YEARS
dosage of troponine
次要结局
未报告次要终点