Quantifying Systemic Immunosuppression to Personalize Cancer Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Clinical endpoint_PFS
研究概览
简要总结
The Serpentine (Stratify cancER PatiENTs by ImmuNosupprEssion) project, represents the most consistent effort so far attempted to translate MDSC into clinical practise by producing an off-the-shelf compliant assay for quantifying these cells in peripheral blood.
详细描述
The study will demonstrate that this assay helps personalizing cancer therapies by tailoring them to immune patient features. The project will also take advantage of innovative and high-throughput techniques to define additional MDSC related biomarkers and, most importantly, to identify novel drugs for Myeloid-derived Suppressor Cells (MDSC) blocking in predisposed patients. Finally,it will perform the first survey assessing the link between MDSC and "perceived social isolation", an emerging western social problem recently shown to cause myeloid cell dysfunction and immunosuppression though neuroendocrine circuits. Globally, the Serpentine proposal has the ambitious goal to translate into the clinical oncological practise the use of MDSC quantification as a tool for the systematic assessment of systemic immunosuppression, providing at the same time operational insights into the strategies to overcome this pillar mechanism of cancer progression.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Clinical endpoint_PFS
时间窗: Through study completion, an average of 2 year
Progression-Free Survival (PFS)
Clinical endpoint_OS
时间窗: Through study completion, an average of 2 year
Overall Survival (OS)
Immunological endpoint
时间窗: Through study completion, an average of 2 year
Frequency, in terms of percentage and absolute count of the defined cell subsets in whole blood and stored PBMC
Clinical endpoint_ORR
时间窗: Through study completion, an average of 2 year
Overall Response Rate (ORR)
次要结局
- Transcriptional signatures_myeloid cells(baseline, that is prior to start the therapy (Visit_1) or at the first disease evaluation (around after three months))
- Transcriptional signatures_PBMC(baseline, that is prior to start the therapy (Visit_1) or at the first disease evaluation (around after three months))
- Phospho-kinome signature result(Through study completion, an average of 2 year)
- Socio-Economical-Psychological (SEP) score(Through study completion, an average of 2 year)
- Myeloid Index Score (MIS)(Through study completion, an average of 2 year)
- Index score values(Through study completion, an average of 2 year)
- Metabolomic profiles(Through study completion, an average of 2 year)