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Clinical Trials in the USA / NCT05370300
Starting soon Observational

SNAPS Breast Cancer Patient Study Breast Cancer Patients

NCT05370300 · tracked via the Priya Life Science USA tracker
Sponsor
Immunis.AI
Phase
Observational
Started
2025-09-01
Last updated
2024-03-06

Condition(s) studied

Breast CancerBreast Cancer Female

Investigational drug(s) / intervention(s)

Blood test

Blood test: Proprietary immunogenomic signature from peripheral blood CD14 and CD2 cells.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Duke University Durham North Carolina

More Immunis.AI trials in the USA

Active Surveillance SNEP Assay Registry Trial for Prostate Cancer Recruiting

Other trials for the same condition

Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study Enrolling by invitation
Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer Active, not recruiting
Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009) Recruiting
Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions) Active, not recruiting
Feasibility Study for the SIRA-1000, SIRA® RFA Electrosurgical Device as an Adjunct to Breast Conserving Surgery Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05370300 on ClinicalTrials.gov ↗ ← All trials in the USA