Observational Study for Breast Cancer Diagnosis Using an Epigenetic Assay
This research study is looking for volunteers, including healthy individuals and those with breast cancer, to help test a new way to diagnose breast cancer. The study will examine changes to your DNA that can be found in a blood test. This new test is called an Epigenetic Assay. The goal is to identify unique patterns in your DNA that are linked to breast cancer. This information could help doctors diagnose breast cancer more effectively in the future. We plan to enroll 450 participants, and the study will last about 5 years. To join, you must be 18 or older, a patient at UMMS, and able to understand and consent to the study in English.
- Study design
- This is an observational study with a planned enrollment of 450 participants, divided into three cohorts of up to 150 subjects each. It is designed to develop and validate a new diagnostic signature.
- What's involved
- You will provide blood samples, have your medical records reviewed, and fill out questionnaires at different times over approximately 5 years. Blood samples will be collected during your routine clinic visits.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints, such as identifying the methylation signature and technology validation, are measured at 5 years, indicating a follow-up period of that length.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Signature Development and Validation Protocol for an Epigenetic Assay in Diagnosing Breast Cancer
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Identification of tumor-associated host methylation signature5 years
Genome-wide methylation profile of whole blood from lung cancer patients, pre-cancer patients, patients undergoing therapy, and control subjects.
- Technology development5 years
The investigators will develop array-based assays using whole-blood samples, focused on disease-specific methylation sites to provide early diagnosis, prognosis, and therapeutic efficacy prediction.
- Technology validation5 years
The investigators will validate identified blood-based circulating methylation signatures in patients with undiagnosed pulmonary nodules.