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Decision Impact Study of PreciseDx Breast
Sponsor: Precise Dx, Inc.
Summary
The investigator's developed a digital LDT to predict invasive breast cancer (IBC) recurrence within 6 years by combining histologic features extracted from an H\&E image of the patients IBC with clinical data including the patients age, tumor size, stage and number of positive lymph nodes. The development of an artificial-intelligent (AI)-grade provides not only an objective, quantitative advancement of classical breast cancer grading but also improves upon the accuracy and utility of clinical risk. The investigator's sought to understand how such a PreciseDx Breast would be used in clinical practice post-surgical resection for women with early-stage IBC.
Official title: Prospective Clinical Utility / Decision Support Study of an AI-enabled Digital Breast Cancer Test (Precise Dx Breast, PDxBRTM) to Predict Early-stage Breast Cancer Recurrence Within 6 Years
Key Details
Gender
FEMALE
Age Range
23 Years - Any
Study Type
OBSERVATIONAL
Enrollment
300
Start Date
2025-08
Completion Date
2029-05-30
Last Updated
2025-05-29
Healthy Volunteers
Yes
Conditions
Interventions
Standard of Care
To use the patients age, tumor size, grade, and lymph node status and any genomic tests (i.e. OncotypeDx, MammaPrint etc to determine risk of recurrence,