Development and Progression of Carcinoid Heart Disease in a Cohort of Adult Patients With Neuroendocrine Tumors Carcinoid Heart Disease (CHD): An Observational French Multi-Centre Cohort Study CRUSOE - NETs (CaRdiac UltraSonic OutcomEs - NETs)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 670
- 试验地点
- 19
- 主要终点
- Carcinoid Heart Disease
研究概览
简要总结
Carcinoid Heart Disease (CHD) is a rare form of heart disease, occurring in over 50% of the patients with carcinoid syndrome. Pathophysiology, prognostic factors of development of Carcinoid Heart Disease and progression of disease remain unclear.
This observational multicenter cohort study is designed to study the occurrence of Carcinoid Heart Disease in patients with differentiated carcinoid tumors, to describe numerous factors influencing the occurrence, severity, progression and long-term survival of patients with Carcinoid Heart Disease. Basic informations and detailed diagnosis informations (oncological and cardiac parameters), are collected by professional doctors. Clinical outcomes (onset of Carcinoid Heart Disease, cardiac surgery, related death) will be followed up every year or every six/three months if clinically indicated.
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
- •Patients over 18 years
- •Patients followed in a NeuroEndocrine Tumor center with a reference cardiologist
- •Patient with:
- •Histologically documented metastatic well-differentiated ileum neuroendocrine tumor or
- •Histologically documented metastatic well-differentiated bronchial neuroendocrine tumor, or
- •Histologically documented well differentiated neuroendocrine tumor, regardless of the primitive site or unknown primitive site and presenting a carcinoid syndrome and / or an elevation of urinary 5HIAA > 2 fold the upper limit of normal range
- •Information given to the patient and his documented non-opposition
排除标准
- •Poorly differentiated neuroendocrine carcinoma
- •Patient unable / unwilling to follow the cardiac monitoring recommended by good practice data
- •Any medical, geographical, sociological, psychological or legal situation that does not allow the patient to complete the study
结局指标
主要结局
Carcinoid Heart Disease
时间窗: 10 years (at the end of study)
Percentage of patients with carcinoid heart disease at diagnosis and during follow-up (carcinoid heart disease diagnosis will be assessed by an annual echocardiography).
次要结局
- Survival(10 years (at death or at the end of study))
- Cardiac surgery(10 years (at the end of study))
- 5HIAA levels(10 years (at the end of study))