Study of the Kinetics of Microparticles Under Chemotherapy in Patients With Gastric or Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Microparticles level will be assessed by automated and standardised measure of their procoagulant power using Kit STA©Procoag-PPL (Diagnostica Stago, Asnière, France)
研究概览
简要总结
Microparticles have recently emerged as a thrombotic risk marker with a potential role in determining which patients are at greatest risk for developing thrombosis. Available data show an increase in the level of microparticles in cancer patients who are undergoing chemotherapy for solid tumors with a possible link to their thrombogenic state.
Our study focuses on the kinetics of microparticles under chemotherapy in patients with pancreatic or gastric cancer by serial measurements of microparticles procoagulant activity.
Detailed Description:
The impact of chemotherapy on microparticles expression will be assessed by measuring their procoagulant activity on blood samples taken during the course of chemotherapy. The thrombotic risk will be evaluated by the score of Khorana in parallel. Microparticles expression in patients with thrombosis will be compared to that in other patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •First-line chemotherapy indicated and accepted by the patient for pancreatic cancer or gastric cancer
- •Confirmed diagnosis of pancreatic cancer or gastric cancer
- •Free subject, without guardianship or trusteeship or subordination
- •Patient benefiting from a social security scheme or benefiting through a third party
- •Consent given by the patient after clear and fair information about the study
排除标准
- •Age < 18yo
- •Life expectancy ≤10days
- •Deep vein thrombosis ou pulmonary embolism ≤3months
- •Patient unable to receive chemotherapy (sepsis, acute coronary syndrome, recent stroke, heparin-induced thrombocytopenia, disseminated intravascular coagulation)
- •Person enjoying enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, and finally patients in emergency situations
- •Pregnant or lactating woman and woman of childbearing age lacking effective contraception
结局指标
主要结局
Microparticles level will be assessed by automated and standardised measure of their procoagulant power using Kit STA©Procoag-PPL (Diagnostica Stago, Asnière, France)
时间窗: After 6 hours of chemotherapies #1 to #6
次要结局
- Khorana score does assess the risk of thrombosis uner chemotherapy according to 3 levels :Score 0, 1, 2 or 3(Before chemotherapies #1 to #6)
- incidence of thrombosis during study(Before chemotherapies #1 to #6 and one year after inclusion.)