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

Part of paid clinical trials in Glen Burnie, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT07374796
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Epigenetic Assay — OTHER
    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.

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Jan 2026
Primary completion
Jun 30, 2032
Completion
Jul 31, 2032

Study Design

Enrollment
450 participants (estimated)

Arms

  • Arm: Study Population 1
    This study population will consist of individuals who have a diagnosis of breast cancer and have not received chemotherapy treatment for their breast cancer. Individuals who have received surgical resection and/or radiation therapy and/or endocrine therapy for their breast cancer will be included.
  • Arm: Study Population 2
    This study population will consist of individuals who have a diagnosis of breast cancer and have received chemotherapy treatment for their breast cancer. All stages of breast cancer will be included including individuals in remission.
  • Arm: Study Population 3
    This study population will consist of individuals who are at high risk of developing breast cancer.

Primary Outcome Measure

Identification of tumor-associated host methylation signature [ Time Frame: 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland Baltimore Washington Medical CenterGlen BurnieMaryland21061
Peter Olivieri, MD
[email protected]
410-553-8241
Cynthia Drogula, MD (SUB_INVESTIGATOR)
Jeffrey Marshall, MD (SUB_INVESTIGATOR)
Harvinder Singh, MD (SUB_INVESTIGATOR)

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By research site
University of Maryland Baltimore Washington Medical Center· Glen Burnie, MD

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