MedTrace Logo

Decision Impact Study of PreciseDx Breast

NCT06309615 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-05-29

No results posted yet for this study

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.

Conditions

Interventions

OTHER

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,

Sponsors & Collaborators

  • Mount Sinai Hospital, New York

    collaborator OTHER

  • Precise Dx, Inc.

    lead INDUSTRY

Principal Investigators

  • Gregory S Henderson, MD, PhD · MOUNT SINAI HOSPITAL

Eligibility

Min Age
23 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-31
Primary Completion
2026-08-31
Completion
2029-05-30

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06309615 on ClinicalTrials.gov