SNAPS Breast Cancer Patient Study Breast Cancer Patients

Not yet recruiting

• Conditions: Breast Cancer; Breast Cancer Female

• Registration Number: NCT05370300
• Lead Sponsor: Immunis.AI

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-05-06
• Study First Submitted QC: 2022-05-06
• Study First Posted: 2022-05-11
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06
• Study Start: 2025-09-01
• Primary Completion: 2026-09-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Aim	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 Outcome Measures

Name	Time	Method
Secondary Aim 2	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.
Secondary Aim 3	12 months	To determine the temporal relation between biopsy procedures and signal strength or dilution.
Secondary Aim 1	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.

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States