Observational Epidemiological Study of Cancer-associated Thrombosis: Registry of Thrombosis & NEoplasia of SEOM (TESEO Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 700
- 试验地点
- 48
- 主要终点
- Characteristics of treatment administered for cancer
研究概览
简要总结
Epidemiological, observational, non-interventional, multicentric study on patients diagnosed with cancer who develop a venous or arterial thromboembolic episode, symptomatic or incidental, within a month prior to cancer diagnosis or at anytime after such diagnosis
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Over 18 years of age with a histologically confirmed diagnosis of malignant tumor.
- •Venous or arterial thromboembolism episode, symptomatic or incidental, in the month prior or any time after the cancer diagnosis and in the three previous months to enrollment, confirmed with an imaging technique: Doppler echocardiography, computed tomography (CT) angiography, etc.
- •Signing of informed consent.
排除标准
- •Clinical diagnosis of thromboembolic event without radiological confirmation.
- •Presenting a single episode of superficial thrombophlebitis without association with another thromboembolic event.
- •Each patient will be recorded just once, and therefore a second thromboembolic event will be considered a rethrombosis and will be recorded as such. Patients with a rethrombosis and a previous thromboembolic event before the start of the study in each center will not be able to be included.
结局指标
主要结局
Characteristics of treatment administered for cancer
时间窗: Baseline
Based on the number of patients prescribed with chemotherapy, radiation therapy, hormonal therapy, erythropoietin, transfusions, surgery, catheter, etc.
Location of origin of the thromboembolytic event
时间窗: Baseline
Distribution in the number of patients according to the anatomical location affected by the thromboembolytic event.
Time between cancer diagnosis and thromboembolic event
时间窗: Baseline
Based on date on confirmed diagnosis of cancer (primary tumor) and date of thromboembolic event
Patient situation at the last visit
时间窗: 12 months
Number of patients with rethrombosis, bleeding, other complications, tumor progression or death.
Vessel of origin of the thromboembolytic event
时间窗: Baseline
Distribution in the number of patients according to the type of vessel affected by the thromboembolytic event.
Thromboembolytic event diagnosis type
时间窗: Baseline
Proportion of patients with incidental versus symptomatic thormboembolic events
Tumor-Node-Metastasis classification
时间窗: Baseline
Based on the American Joint Committee on Cancer 2018 Tumor-Node-Metastasis classification system: T for extent or size of the tumor, N for lymph nodes spread and M for metastasis.
Primary tumor at the time of the thromboembolic event
时间窗: Baseline
Distribution of patients according to the organ affected by the primary tumor.
次要结局
未报告次要终点