SNAPS Breast Cancer Patient Study Breast Cancer Patients

March 5, 2024 updated by: Immunis.AI

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University
        • Contact:
          • Amanda Nash
          • Phone Number: 855-855-6484
        • Contact:
          • Amanda Nash
        • Principal Investigator:
          • Shelley Hwang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Controls: Patients with negative screening MMG
Patients presenting to Duke Radiology for routine screening mammogram will be screened for eligibility as negative controls. Study enrollment for negative controls presumes that patients do not receive their screening mammography results immediately. Patients will be approached on the day of their first new patient visit to the Duke Cancer Center. If they are willing, they will be consented in clinic, and directed down to the lab for their first blood draw.
Diagnostic test: Blood test
Proprietary immunogenomic signature from peripheral blood CD14 and CD2 cells.
Cases: Patients with known cancer diagnosis
Patients presenting to the Duke Cancer Center for evaluation by Medical or Surgical Oncology of a newly diagnosed breast cancer will be screened for study eligibility and approached, enrolled, and consented accordingly. Patients will be approached on the day of their first new patient visit to the Duke Cancer Center. If they are willing, they will be consented in clinic, and directed down to the lab for their first blood draw.
Diagnostic test: Blood test
Proprietary immunogenomic signature from peripheral blood CD14 and CD2 cells.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
12 months
Secondary Aim 3
Time Frame: 12 months
To determine the temporal relation between biopsy procedures and signal strength or dilution.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Immunis.AI

Collaborators

Duke University

Investigators

  • Principal Investigator: Kirk Wojno, MD, Immunis.AI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

May 6, 2022

First Submitted That Met QC Criteria

May 6, 2022

First Posted (Actual)

May 11, 2022

Study Record Updates

Last Update Posted (Actual)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNAPS Breast Cancer

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Research data will not be shared as it is proprietary information

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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