Role of Hyaluronic Acid in Cancer Stem Cell Niche
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- HAS2 expression, measured by single-cell PCR
研究概览
简要总结
This research trial studies the role of a substance called hyaluronic acid in causing the growth of cancer stem cells in the bones of patients with breast cancer. Cancer stem cells are a type of cancer cells that may cause the cancer to spread to other parts of the body. Studying samples of blood and bone marrow from patients and animal models in the laboratory may help doctors learn more about whether hyaluronic acid affects the growth of cancer in the bones.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the hypothesis that there are more hyaluronan synthase 2 (HAS2)+ cells in patients with bone metastasis compared to patients with only local disease.
SECONDARY OBJECTIVES:
I. To evaluate the hypothesis that cells with HAS2+ and cancer stem cell (CSC)+ (cluster of differentiation [CD]24-/CD44+/epithelial specific antigen [ESA]+) cells will have the most aggressive growth in the bone, using an animal model.
OUTLINE:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must have newly diagnosed, histologically confirmed primary and/or metastatic breast cancer
- •Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document
排除标准
- •Patients who have had chemotherapy or radiotherapy
结局指标
主要结局
HAS2 expression, measured by single-cell PCR
时间窗: Baseline
Descriptive statistics will be generated. The relationship of each cell's bone metastatic ability and HAS2 expression will be examined using correlations within each group between these two measures. The mean values of the HAS2 expression and bone metastatic ability will be compared between groups using one-way analysis of variance (ANOVA) models. In addition, 2-sample t-tests will be used to compare the primary cancer and bone metastases groups.
次要结局
- CSC marker expression(Baseline)