Clinical Trial

Signature Development and Validation Protocol for an Epigenetic Assay in Diagnosing Breast Cancer

Not Yet Recruiting
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Summary
The purpose of this research study is to test a new process for diagnosing breast cancer by examining changes to your DNA that can be detected from a blood test. The information we learn by doing this study could potentially help people in the future. Participants in this study will have blood samples collected, have their medical records reviewed by study personnel and fill out questionnaires at different time points during the study. Blood sample collection will occur during normal routine clinic visits. Participation in this study will last approximately 5 years.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2032-03 -> 2032-06 2026-04-23
minor Completion pushed: 2032-04 -> 2032-07 2026-04-23
Trial Details
NCT Number NCT07374796
Lead Sponsor University of Maryland, Baltimore
Collaborators: EPOCH Epigenetics, Inc
Conditions Breast Cancer (Locally Advanced or Metastatic), Healthy Volunteers (HV), Unhealthy Volunteers, Breast Cancer Screening
Enrollment 450 participants
Start Date 2026-06-01
Primary Completion 2032-06 (estimated)
Study Completion 2032-07 (estimated)
Updated on ClinicalTrials.gov 2026-04-22