Organoid Model Predictive of Response to Immunotherapies
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Calculate overall patient response rate
研究概览
简要总结
The purpose of this study is to create models out of tissue samples and treat those models with the same immunotherapy treatment the patient will be receiving, in order to validate this process and to predict responses to therapies and use it to choose the best treatments for people in the future. The researchers will then examine the direct effects of the treatment on those models.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •≥ 18 years old at the time of informed consent
- •Ability to provide written informed consent and HIPAA authorization
- •Biopsy proven diagnosis of cancer
- •Able to obtain at least 2 16 gage cores of fresh tissue safely (3 or more cores preferred)
- •Planning to undergo standard of care Immunotherapy
- •Baseline standard of care CT within 8 weeks of starting Immunotherapy
排除标准
- •Inability to provide fresh biopsy sample
- •Any active infections
- •Any conditions that in the opinion of treating physician and the study team will compromise the ability of the patient to receive prescribed treatment to assess the response.
结局指标
主要结局
Calculate overall patient response rate
时间窗: Baseline to 12 months
Compare patient response using RECIST 1.1 criteria and immune-organoid response based on the following criteria: 1. Complete response \<50% of viable tumor cells 2. Response \>50%\<70% of viable tumor cells 3. Stable \>70%\<90% viable tumor cell left 4. Progressive \>90% of viable tumor cell left
Reliability of organoid development
时间窗: Baseline to 2 months
calculate the percentage of biopsies with successful organoid development
次要结局
未报告次要终点
研究者
Mateusz Opyrchal
Associate Professor of Medicine, Vera Bradley Foundation Scholar in Breast Cancer, Program Leader - Phase 1
Indiana University