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临床试验/NCT05370300
NCT05370300尚未招募不适用

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

Immunis.AI1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2025年9月1日最近更新:
适应症

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

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)

研究者

发起方
Immunis.AI
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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