Establishment of a Patient-based Cohort : Cancer-related Venous Thromboembolic Disease.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- Venous thromboembolic recurrence
研究概览
简要总结
Venous thromboembolic disease (VTE) is a common (1/1000), potentially serious disease (10% mortality when the clinical presentation is that of pulmonary embolism (PE)). In cancer patients, the risk of developing VTE is high and constitutes a negative prognostic factor for cancer; the risk of bleeding is also increased. The study of VTE in the context of cancer is a major challenge, given the frequency of the association, the heterogeneity of the situations, the risk factors involved and the therapeutic issues in both curative and primary prevention; in this field, many uncertainties remain, justifying a study focused on the association of VTE and cancer.
详细描述
Cancer is associated with a higher risk of VTE and mortality. This association is characterized by various uncertainties at pathophysiological, diagnostic, therapeutic and prognostic levels.
CAPE STUDY is a prospective, single-center interventional cohort follow-up study designed to investigate the risk of recurrence of VTE and its mechanisms in cancer patients.
The study involves the collection of biological samples from cancer patients with venous thromboembolic disease.
At inclusion and in case of recurrence of thrombosis or hemorrhage:
- Blood samples will be taken for analysis and to constitute a biobank for future assays.
- Urine samples will be collected Once a year for 5 years (and adapted to the clinical context): visit as part of routine care, or mailing of a questionnaire, or telephone contact.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years and more.
- •Patients with active cancer or requiring cancer treatment at the time of their VTE episode
- •Patients with documented VTE less than 2 years old
- •Patients affiliated to the social security system
- •Patient who has signed a written informed consent
排除标准
- •Patient under 18
- •Refusal to participate
- •Incapacity to consent to the study
- •Patient under guardianship
- •Incapacity to communicate (comprehension disorder)
- •Life expectancy of less than 6 months
结局指标
主要结局
Venous thromboembolic recurrence
时间窗: 5 years
Venous thromboembolic recurrence
次要结局
- Arterial events(5 years)
- Mortality(5 years)
- Major hemorrhage(As long as the patient is on anticoagulant treatment during the 5 years of follow-up)