A Feasibility Study Of Developing Murine Primary Xenografts From Biopsies Of Liver Metastases In Patients With Advanced Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Engraftment rate compared to clinical data (response to treatment, disease-free survival, overall survival)
研究概览
简要总结
This is a feasibility study to perform image-guided liver biopsies in 25 patients who have pancreatic cancer with liver metastasis (cancer in the pancreas that has spread to the liver). This will contribute with samples for the bio-bank (bank of tumors) and develop xenografts (human tumors growing in mice) for further analysis of genes.
详细描述
This study might bring a better understanding of the metastatic pancreatic cancer and evaluate the differences between the metastatic and the primary pancreatic cancer (the type that does not have metastasis).
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
- •Minimum age of 18 years old
- •Pancreatic cancer with liver metastasis
- •No contraindication to image-guided biopsy of liver metastasis, including uncontrolled bleeding diathesis, uncontrolled malignant pain, inability to lie supine etc) and no significant hepatic dysfunction.
- •Provide written informed consent
- •ECOG 0,1 or 2
排除标准
- •Inability to lie supine for more than 30 minutes
- •ECOG 3 or more
- •Serious medical risk factors involving any of the major organ systems or including uncontrolled bleeding diathesis, uncontrolled malignant pain, inability to lie supine etc) and no significant hepatic dysfunction.
结局指标
主要结局
Engraftment rate compared to clinical data (response to treatment, disease-free survival, overall survival)
时间窗: up to date of death from any cause
determine the correlation between engraftment rate and clinical data (response to treatment, disease-free survival, overall survival).
Number of similarities and differences between original patient tumor sample with xenograft sample
时间窗: up to 2 years
complete histological and molecular comparison of original patient sample with murine xenograft
Number of patients with adverse events due to biopsies
时间窗: up to 2 years
Monitoring adverse events during trial related to biopsies
Number of successful xenografts
时间窗: up to 2 years
determine the "take rate" or success of establishing xenografts
次要结局
未报告次要终点