Prospective Evaluation of the Treatment of Cancer Associated Superficial Venous
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,576
- 试验地点
- 1
- 主要终点
- risk (in %) of recurrence of VTE
研究概览
简要总结
Superficial venous thrombosis (SVT) is very common in clinical practice. What's more, around 15- 20% of SVTs occur in the context of cancer. Today, cancer patients are excluded from therapeutic trials for DVT. There is therefore no high-level evidence-based treatment recommendation for these patients. Recent data suggest that the course of cancer-associated DVT is similar to that of cancer-associated deep vein thrombosis (DVT). However, there are currently few prospective data on the evolution of cancer-associated DVT in relation to the treatment used. Due to the absence of clear recommendations of treatment in case of SVT associated with cancer the investigators will perform a prospective observational study to evaluate the efficacy of different regiment of anticoagulant treatment ordered in clinical practice.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient over 18
- •Patient affiliated to a social security scheme
- •Patient who understands French
- •Patient with superficial venous thrombosis of the lower and upper limbs confirmed by a Doppler ultrasound less than one month old.
- •Patient with active cancer:
- •Cancer treatment within the last 6 months,
- •Detectable tumor disease, cancer treatment within the last 6 months, ongoing hormone therapy for cancer, palliative cancer.
- •The patient has received potentially non-curative cancer treatment (notably palliative chemotherapy).
- •Progression shows that the cancer treatment was not curative (due to recurrence or progression under treatment) (particularly in the case of recurrence after surgery)
排除标准
- •Patients under legal protection
- •Patients with concomitant pulmonary embolism
- •Patient with proximal or distal deep vein thrombosis
- •Patient treated with anticoagulant therapy for another indication
- •Patient with a contraindication to anticoagulation: Thrombocytopenia less than 30,000 elements/mm3, active bleeding or history of severe bleeding.
- •Patient opposed to participation in research
结局指标
主要结局
risk (in %) of recurrence of VTE
时间窗: at 3-month follow-up
risk of recurrence of VTE at 3-month follow-up in patients with cancer-associated SVT.
次要结局
- rates of recurrence of symptomatic vs. incidental VTE(at 12 months)
- association (%) between initial treatment and the risk of SVT recurrence(at 3 months)
- association (%) between initial treatment and the risk of SVT recurrence(at 6 months)
- Association (%) between initial treatment and the occurrence of pulmonary embolism (PE)(at 12 months)
- Association (%) between initial treatment and the occurrence of pulmonary embolism (PE)(at 3 months)
- Association (%) between initial treatment and the occurrence of DVT(at 3 months)
- Association (%) between initial treatment and the occurrence of DVT(at 12 months)
- association (%) between initial treatment and bleeding events(at 6 months)
- association (%) between initial treatment and bleeding events(at 3 months)
- association(%) between initial treatment and all-cause death(at 3 months)
- association(%) between initial treatment and all-cause death(at 6 months)
- rates of recurrence of symptomatic vs. incidental VTE(at 3 months)
- rates of recurrence of symptomatic vs. incidental VTE(at 6 months)
- association(%) between initial treatment and all-cause death(at 12 months)
- association (%) between initial treatment and the risk of SVT recurrence(at 12 months)
- association (%) between initial treatment and bleeding events(at 12 months)
- Association (%) between initial treatment and the occurrence of pulmonary embolism (PE)(at 6 months)
- Association (%) between initial treatment and the occurrence of DVT(at 6 months)
- rate of confirmed cancer in patients with TVS suspected of having cancer.(at 12 months)