Signature Development and Validation Protocol for an Epigenetic Assay in Diagnosing Breast Cancer
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.
Description
This clinical testing protocol outlines the validation process for an epigenetic assay targeting host peripheral blood cell and the associated host DNA methylation signatures designed to diagnose breast cancer. The overall protocol process will involve three distinct stages representing three patient cohorts with up to 150 subjects per cohort across 3 populations of patients. Cohort one will act as signature development phase; cohort two will act as signature finalization phase; and cohort three will act as a validation cohort phase. Each cohort with include the following patient populations w…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * 18 years old or older * Patient of UMMS * Willing and able to consent to study procedures listed in the protocol * Ability to speak and understand English Exclusion Criteria: * Younger than 18 years old * Patient not cared for at UMMS * Unable to consent to study procedures listed in the protocol * Unable to speak or understand English
Interventions
- OtherEpigenetic 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.
Location
- University of Maryland Baltimore Washington Medical CenterGlen Burnie, Maryland