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Signature Development and Validation Protocol for an Epigenetic Assay in Diagnosing Breast Cancer
Sponsor: University of Maryland, Baltimore
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
450
Start Date
2026-02-01
Completion Date
2032-04
Last Updated
2026-01-29
Healthy Volunteers
Yes
Conditions
Interventions
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.
Locations (1)
University of Maryland Baltimore Washington Medical Center
Glen Burnie, Maryland, United States