Evaluation of Cryo-Immune Stimulation in Mesothelioma
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Preponderance of T cells in ablated tumor tissue in comparison to non-cryoablated tissue
研究概览
简要总结
This trial evaluates if cryoablation will stimulate a local immune response by cluster of differentiation 8 positive (CD8+) cells which are not present in ablation naive regions of the tumors in patients with mesothelioma. Cryoablation uses extreme cold to damage or destroy tumor lesions. Mesothelioma is a rare cancer that grows and spreads quickly, and has low survival rates. The information learned from this study may provide evidence as to whether there is a measurable, local immune response from cryoablation. Studying samples of mesothelioma tissue in the laboratory from patients who have undergone biopsy may help doctors learn more about the effects of cryoablation on cells. It may also help doctors understand how well patients respond to treatment.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the simple hypothesis that cryoablation of mesothelioma will promote local tumor infiltration by cytotoxic cluster of differentiation 8 positive (CD8+) cells that will not be present in ablation naive regions of the tumors.
II. To determine whether there is a preponderance of T cells in ablated tumor tissue in comparison to non-cryoablated tissue.
OUTLINE:
At the time of standard of care pleural biopsy, patients undergo cryoablation over 30 minutes, then a sample of tissue from the ablated region and a non-ablated (tumor negative control) region are collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults that have been identified at tumor board with high suspicion for mesothelioma and are anticipated to be surgical candidates, as determined/discussed at Mesothelioma Tumor Board
排除标准
- •Patients that have a questionable diagnosis of mesothelioma (i.e. there are other potentially more likely considerations in the differential diagnosis) or in patients that would not be expected to be good surgical candidates
结局指标
主要结局
Preponderance of T cells in ablated tumor tissue in comparison to non-cryoablated tissue
时间窗: Up to 1 year
Subsequent fluorescence activated cell sorting for cluster of differentiation 4 positive (CD4+) and CD8+ markers will be performed to identify sub-populations of lymphocytes. The counts will be compared using a one-way paired t-test (two samples from each patient; ablated and non-ablated). The isolated cells will be frozen for potential subsequent use (if the hypothesis for the study is true then subsequent profiling of the cells will be performed, such whole exome sequencing (ribonucleic acid-sequencing) and metabolomic profiling).
Local tumor infiltration by cytotoxic cluster of differentiation 8 positive (CD8+) cells
时间窗: After cryoablation of mesothelioma up to 1 year
Will be tested by cryoablating a small region of tumor at the time of pleural biopsy.
次要结局
未报告次要终点