Biomarkers For Immune Checkpoint Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- To determine serum predictors of response to immune checkpoint inhibitors at study entry, prior to checkpoint inhibitor therapy
研究概览
简要总结
This is a laboratory, non-treatment study. Immune checkpoint inhibitors are a type of immunotherapy that stimulates a patients immune system to fight their cancer. Immune checkpoint inhibitors are standard, FDA approved treatment for certain types of cancers such as melanoma, lung cancer, kidney cancer and bladder cancer. The laboratories of Dr. Jack Elias and Dr. Chun Geun Lee at Brown University are studying how immune checkpoint inhibitors work.Kintai Therapeutics is a biotech company in Cambridge Massachusetts that will focus on the molecules present in the GI tract, including the stomach, small intestine and colon.
详细描述
Patients who are receiving immune checkpoint inhibitors for their cancer treatment are eligible. Patients will sign informed consent. Ten cc of blood will be drawn before beginning immune checkpoint inhibitors and 10 cc of blood will be drawn 1-4 months after treatment is initiated. Deidentitified blood samples will be sent to the lab of Dr. Jack Elias and Dr. Chun Geul Lee and analyzed for biomarkers. The blood samples will be linked to the patient by a research number. Response to treatment will be correlated to potential biomarkers. The stool samples will be linked to the patient by a research number. Bacterial DNA and RNA may be sequenced and data used to identify bacterial taxa and genes within the stool. In compliance with NIH guidelines, all human DNA data would be removed computationally, and will not be used in any analyses. Small molecules may be profiled with metabolomics. Bacteria may also be isolated from the stool into in vitro culture, and efficacy of single-strains or communities and/or their DNA, RNA, and metabolites on disease models may be assessed.
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
- •Patients with advanced solid tumors initiating treatment with an immune checkpoint inhibitor.
- •No prior immune checkpoint inhibitors
- •Signed informed consent
排除标准
- •The patient is unwilling or unable to provide informed consent
结局指标
主要结局
To determine serum predictors of response to immune checkpoint inhibitors at study entry, prior to checkpoint inhibitor therapy
时间窗: At study entry, prior to checkpoint inhibitor therapy Anytime between 6-12 weeks after initiating treatment.
Measure biomarker levels of immune checkpoint inhibitors in blood serum
To determine serum predictors of response to immune checkpoint inhibitors 4-weeks after initiation of treatment
时间窗: Within 4 weeks after initiation of treatment
Measure biomarker levels of immune checkpoint inhibitorsin blood serum
To determine serum predictors of response to immune checkpoint inhibitors anytime between 6-12 weeks after initiating treatment.
时间窗: 6-12 weeks after initiating treatment
Measure biomarker levels of immune checkpoint inhibitors in blood serum
次要结局
- To evaluate bacteria, and bacterial products in gut microbiome before and after treatment with immune checkpoint inhibitors and correlate to response and toxicity.(Anytime between 6-12 weeks after initiating treatment.)