Evaluation of Autologous Natural Killer Cell Activity in Primary Cancer Cell Cultures
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Antitumor activity
研究概览
简要总结
The objectives of the study is to evaluate the anti-tumor activity of autologous natural killer cells in cultures of cancer cells obtained from patient's own tumor.
详细描述
The objectives of the study is to evaluate the anti-tumor activity of autologous natural killer cells in cultures of cancer cells obtained from patient's own tumor.
Study Design:
One hundred mL of blood will be collected in an EDTA container and transported to the laboratory for in vitro isolation and expansion of NK cell cultures.
Two or three weeks later, 25 cu mm of the patient's own tumor will be collected in PBS and transported to the laboratory for co-culture with autologous expanded and enhanced NK cells.
Inclusion Criteria:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Individuals must meet all of the inclusion criteria in order to be eligible to participate in the study, as follows:
- •Male or Female ≥ 18 years of age
- •Pathologically confirmed diagnosis of locally advanced unresectable or metastatic soft tissue sarcoma
- •Patients who are already scheduled for surgery
- •Ability to understand the purposes and risks of the study and has signed and dated a written informed consent form approved by the investigator's IRB/Ethics Committee
- •Willingness to comply with all study procedures and availability for the duration of the study.
排除标准
- •Patients who do not meet inclusion criteria.
结局指标
主要结局
Antitumor activity
时间窗: 1 month
Inhibition of autologous cancer cell growth in vitro by autologous natural killer cells using an automated cell counter. For the in vitro studies, multiple group comparisons at a single time point will be made via the independent analysis of variance (ANOVA) test, followed by Tukey's HSD test as a post-hoc test where appropriate.
次要结局
未报告次要终点