NL-OMON49077已完成不适用
Development of a more sensitive method to predict breast cancer recurrence after 5-years of endocrine treatment making use of diagnostic leukapheresis to detect circulating tumor cells - Sibylla
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational invasive
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •2. Age >18 years
- •3. Diagnosed with ER+ Her2-negative lymph node positive, primary breast cancer
- •4. Received at least 4.5 - 5.5 years of adjuvant ET for breast cancer
- •including those who are <6 months after finishing endocrine therapy.
- •5. No clinical signs of locoregional or distant recurrence.
- •6. At least one adequate peripheral vein in both arms as access for
- •leukapheresis.
- •7. Provide written informed consent
排除标准
- •1. Prior non-breast malignancies <5 years of inclusion, except for basal or
- •squamous cell carcinoma of the skin
- •2. Pre-existing lymphedema, quantified by specialist
- •3. Known hypersensitivity to the used anticoagulant (ACD)
- •4. Inadequate cardiac function or severe cardiovascular comorbidity (heart
- •failure NYHA class III/IV)
- •5. Coagulation disorders as defined by one of the following:
- •NOTE: the use of all types of anticoagulant therapy is permitted
- •o Coagulation disorder in medical history
- •o Platelet count < 40 x 10^9/L;
- •Patients not on anticoagulant therapy which affects PT or APTT if:
- •o PT > 1.5 x ULN or PT-INR > 1.5 x ULN
- •o APTT > 1.5 x ULN
- •Patients who take anticoagulant therapy which affects PT or APTT if:
- •o PT or APTT > 1.5 x the upper limit of the desired therapeutic window
- •o Total bilirubin > 2.5 x ULN
- •6. BMI >= 35 kg/m2
研究者
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