Subtraction Normalized Aggregated Phagocytic Signal in Peripheral Blood of Breast Cancer Patients (SNAPS - Clinical Trial) A NextGen RNASeq Feasibility Study of a Blood-based Model for Early Cancer Detection and Surveillance
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Immunis.AI
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Primary Aim
研究概览
简要总结
Differential immunogenomic signatures from peripheral blood CD14 (phagocytic) and CD2 (non-phagocytic) cells have been associated with multiple cancers and disease states. In particular several large clinical studies at Immunis.AI have demonstrated robust immunogenomic signatures in early-stage prostate cancer. Immunis.AI therefore hypothesizes that a peripheral blood immunogenomic signature will identify patients with various stages of breast cancer from healthy negative controls.
详细描述
Efficient next generation RNA sequencing platforms have allowed for whole genome expression profiling of individual populations of immune cells as a novel means of searching for patterns of gene expression to aid in the identification of meaningful signals unique to various disease states. Single cell sequencing techniques have provided additional information useful in deconvolution strategies applied to model development on purified populations of immune cells. Recent interest in peripheral leukocyte subset gene expression profiles suggests that diagnostic information for many disorders may be contained therein. Mononuclear phagocytic cells including the various CD14+ subsets have been studied extensively in various disease states including some solid tumors. Previous large clinical studies at Immunis.AI have determined that transcriptomic profiles of CD14+ cell populations subtraction normalized from CD2+ cell populations were associated with aggressive disease phenotypes such as prostate cancer. Tumor heterogeneity, multifocality, and oligoclonality have been a significant barrier to development of meaningful tissue based multigene signatures for predicting cancer biologic behavior. The findings at Immunis.AI strongly suggest that analysis of RNA expression data from the body's immune surveillance cells has the potential to summarize the entire heterogeneous tumor. The investigators believe that the CD14/CD2 log ratio can be understood as a subtraction normalization of gene expression which yields superior signal of early-stage cancer.
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 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients > 18 yrs of age.
- •Patients diagnosed with stage I-IV breast cancer, who have not begun definitive therapy.
- •Patients undergoing screening mammograms for breast cancer.
排除标准
- •Patients with a history of a different cancer within the previous 3 years (except non melanoma skin cancer).
- •Any prior treatment (surgery, chemo, hormonal, radiation, biologics, etc.) for current cancer.
- •Any biopsy which resulted in the entire tumor tissue being removed.
- •History of previous breast cancer.
- •Patients unable to provide informed consent.
- •Patients with an abnormal screening mammogram.
- •Patients whose hormone receptor and/or HER2 status are not available.
结局指标
主要结局
Primary Aim
时间窗: 12 months
To determine if differential gene expression between peripheral blood phagocytic and non-phagocytic immune cells can distinguish breast cancer patients from cancer-negative controls.
次要结局
- Secondary Aim 2(12 months)
- Secondary Aim 3(12 months)
- Secondary Aim 1(12 months)
