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

NCT07374796 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 450

Last updated 2026-04-22

No results posted yet for this study

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.

Conditions

  • Breast Cancer (Locally Advanced or Metastatic)
  • Healthy Volunteers (HV)
  • Unhealthy Volunteers
  • Breast Cancer Screening

Interventions

OTHER

Epigenetic Assay

Up to 15 ml of blood will be collected from each patient at various time points throughout their 5 years of participation. DNA extraction, bisulfite conversion and analysis of epigenetic markers through PCR or next-generation sequencing will be performed. An epigenetic signature assay will then be identified.

Sponsors & Collaborators

  • EPOCH Epigenetics, Inc

    collaborator UNKNOWN

  • University of Maryland, Baltimore

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2032-06-30
Completion
2032-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT07374796 on ClinicalTrials.gov