NCT02237170已完成不适用
A Systems Biology Approach to Immune Monitoring in Patients With Castration-resistant Prostate Cancer Receiving SiPuleucel-T
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Change in Regulatory T cells (Tregs)
研究概览
简要总结
The purpose of this protocol is perform comprehensive immune monitoring studies in patients with castration-resistant prostate cancer receiving Sipuleucel-T in an effort to better understand the mechanism of action of this treatment.
详细描述
The primary objectives of this study are to:
- Establish the phenotype and frequency of circulating immune cell compartments in patients undergoing treatment with Sipuleucel-T.
- Determine the induction and the quality of prostate antigen-specific T cell immunity in patients undergoing treatment with Sipuleucel-T.
- Correlate whole-blood RNA transcript-based signatures with clinical outcomes in patients treated with Sipuleucel-T.
- Evaluate the cytokine and chemokine milieu in the peripheral blood pre- and post-treatment with Sipuleucel-T.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years of age
- •Written informed consent obtained
- •Patients with castration-resistant prostate cancer who are initiating Sipuleucel-T as standard therapy
- •No prior systemic chemotherapy for metastatic prostate cancer
- •Hemoglobin > 9 mg/dl
排除标准
- •Patients unable to understand the research protocol and/or provide informed consent
结局指标
主要结局
Change in Regulatory T cells (Tregs)
时间窗: baseline and 1 year
Establish the phenotype and frequency of circulating immune cell compartments in patients undergoing treatment with Sipuleucel-T looking at the change in regulatory T cells at 1 year post treatment compared to at baseline
次要结局
- Change in Antigen Presenting Cells(baseline and 1 year)
- Change in Prostate Antigen-specific T Cell Immunity(baseline and one year)
- Change in chemokine milieu(baseline and 1 year)
- Whole-blood RNA transcript-based signatures(up to 1 year)
- Change in cytokine milieu(baseline and 1 year)
研究者
研究点 (3)
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