NCT06469710招募中不适用
A Trial to Evaluate the Effect of Applying Leukapheresis to Enrich CTCs in Patients With Metastatic Prostate Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of circulating tumor cells
研究概览
简要总结
The goal of this observational study is to compare the number of CTCs enriched by both sampling methods, leukapheresis and collection of peripheral blood in metastatic prostate cancer patients. The main questions it aims to answer are:
- The advantages and disadvantages of two sampling methods for further diagnosis and treatment;
- How to obtain further information on the tumour biology of CTC;
- The mechanisms of prostate cancer invasion and metastasis Participants will have 7.5mL of peripheral blood taken as well as undergo leukapheresis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •male, aged 18-75 years; and
- •Evidence of metastasis (positive finding of metastasis on one of the following tests: CT and MRI; whole-body nuclear bone imaging, fluoride PET and PET-CT, cholinergic PET-CT and MRI; prostate-specific membrane antigen-targeted PET-CT); or clinical diagnosis of metastatic prostate cancer (tumour stage of T3 and above) by pathology of aspiration/surgical biopsy;
- •Good general condition, ECOG score 0-1, able to tolerate leukapheresis;
- •Normal haematological analysis, liver and renal function tests at screening;
- •Subjects (or their legal representatives) can understand the informed consent form.
排除标准
- •those who have received systemic combination therapy for tumours within 5 years;
- •those with poor general condition, severe haemodynamic instability, malignant arrhythmias, cachexia and infections
- •those with coagulation disorders, DIC or reduced platelets;
- •those receiving exogenous plasma at the time of the trial;
结局指标
主要结局
Number of circulating tumor cells
时间窗: The leukapheresis takes about 2 hours, and CTCs number will be measured in 24 hours after sampling.
Measurement of the number of CTCs enriched from different samples
次要结局
未报告次要终点
研究者
Liang Dong
vice president of Renji Hospital
RenJi Hospital
研究点 (1)
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