Using Induced-Pluripotent Stem Cells to Model Cancer Therapy-Related Adverse Events
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- In vitro measurement of cellular viability in response to chemotherapy
研究概览
简要总结
This study is being done to find out if patient blood samples can be used to perform individualized modeling of cancer therapy-related side effects.
详细描述
PRIMARY OBJECTIVES:
I. Generate induced pluripotent stem cells (iPSC's) from patients receiving cancer treatment.
II. Differentiate patient iPSC's into cardiomyocytes and/or neurons or other cell types that may be relevant to modeling cancer therapy-related adverse effects, such as cardiotoxicity and neurotoxicity.
III. Use patient specific iPSC-derived cells to:
IIIa. Model cancer therapy-related toxicities; IIIb. Better understand the mechanisms of toxicities; IIIc. Determine if patient specific genetic variants are causative of toxicities; IIId. Screen novel protective therapies for cancer therapy-related toxicities.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •Any patient >= 18 years of age
- •Previously treated, planned or currently receiving any potentially toxic cancer therapy including but not limited to chemotherapy, targeted and immunotherapies
排除标准
- •Inability on the part of the patient to understand the informed consent or be compliant with the protocol
研究组 & 干预措施
Observational
Patients undergo blood sample collection and have their medical records reviewed on study.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
In vitro measurement of cellular viability in response to chemotherapy
时间窗: Blood drawn at enrollment to obtain sample
Will be compared between cells derived from patients who experienced treatment-induced toxicity to cells derived from patients who received the same cancer therapy without toxicity. Statistical analyses of different endpoints will use Fisher's exact test, one-way ANOVA test followed by all-pairwise-multiple-comparison procedures, or an unpaired, two-tailed Student's t-test with significant differences defined by P \< 0.05.
次要结局
未报告次要终点