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NCT Number: NCT05370300

SNAPS Breast Cancer Patient Study Breast Cancer Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Duke University

Durham, North Carolina, 27710, United States

Location contact

Amanda Nash

CONTACT

855-855-6484

Amanda Nash

CONTACT

Shelley Hwang, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Blood test

Diagnostic Test

Proprietary immunogenomic signature from peripheral blood CD14 and CD2 cells.

Primary outcomes

  1. Primary Aim

    Time frame: 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.

Secondary outcomes

  1. Secondary Aim 1

    Time frame: 12 months

    To evaluate minimal residual disease with a potential signature for breast cancer detection following curative therapy to evaluate the degree to which the original signature has changed.

  2. Secondary Aim 2

    Time frame: 12 months

    To determine the sample size required to develop and validate a computational immunogenomic model capable of predicting the various types, grades, and stages of breast cancer.

  3. Secondary Aim 3

    Time frame: 12 months

    To determine the temporal relation between biopsy procedures and signal strength or dilution.

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda Nash

CONTACT

[email protected]

855-855-6484

Sponsors and collaborators

Lead sponsor

Immunis.AI

Industry

Collaborators

  • Duke University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 11, 2022
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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