SNAPS Breast Cancer Patient Study Breast Cancer Patients

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Immunis.AI
Study ID
NCT05370300
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Blood test — DIAGNOSTIC_TEST
    Proprietary immunogenomic signature from peripheral blood CD14 and CD2 cells.

Study Details

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.

Key Dates

Start date
Sep 1, 2025
Status verified
Mar 2024
Primary completion
Sep 30, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Primary Aim [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke UniversityDurhamNorth Carolina27710
Amanda Nash
855-855-6484
Amanda Nash
Shelley Hwang, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Durham, NC

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Duke University· Durham, NC

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