Clinical trial NCT05370300: SNAPS Breast Cancer Patient Study Breast Cancer Patients
Official 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer
Breast Cancer Female
Keywords: Breast Cancer
Immunogenomics
Lead sponsor: Immunis.AI
Sponsor class: INDUSTRY
Collaborators: name: Duke University
First posted: 2022-05-11
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting to the Duke Cancer Center for evaluation by Medical or Surgical Oncology of a newly diagnosed breast cancer Patients presenting to Duke Radiology for routine screening mammogram

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary Aim
timeFrame: 12 months
Secondary outcomes:
measure: Secondary Aim 1
timeFrame: 12 months
measure: Secondary Aim 2
timeFrame: 12 months
measure: Secondary Aim 3
timeFrame: 12 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Immunis.AI
name: Kirk Wojno, MD
role: PRINCIPAL_INVESTIGATOR
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