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SNAPS Breast Cancer Patient Study Breast Cancer Patients

ConditionsBreast CancerBreast Cancer Female
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorImmunis.AI

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Blood test

    Diagnostic test

    Proprietary immunogenomic signature from peripheral blood CD14 and CD2 cells.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Controls: Patients with negative screening MMG1 intervention
Group B: Cases: Patients with known cancer diagnosis1 intervention

Trial outcomes

Primary outcomes

1

Primary Aim

To determine if differential gene expression between peripheral blood phagocytic and non-phagocytic immune cells can distinguish breast cancer patients from cancer-negative controls.

Time frame
12 months

Secondary outcomes

1

Secondary Aim 1

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.

Time frame
12 months
2

Secondary Aim 2

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.

Time frame
12 months
3

Secondary Aim 3

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

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Immunis.AI

Lead sponsor

Duke University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: