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

University of Maryland Baltimore (UMB)

Status: Not yet enrolling

Conditions: Breast Cancer Screening; Healthy Volunteers (HV); Unhealthy Volunteers; Breast Cancer (Locally Advanced or Metastatic)

Treatments: Other: Epigenetic Assay

Study type: Observational

Funder types: Other

Identifiers

NCT07374796

HP-00117656

Details and patient eligibility

About

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.

Full 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 with up to 50 patients per population:

1. Breast cancer, NO chemotherapy. Includes patients treated with surgical resection and/or radiation therapy and/or endocrine therapy
2. Breast cancer who have received chemotherapy. Includes all stages including remission
3. At risk group (patients at increased risk for breast cancer followed in a high risk breast program)

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

450 participants in 3 patient groups

Study Population 1

Description:

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.

Treatment:

Other: Epigenetic Assay

Study Population 2

Description:

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.

Treatment:

Other: Epigenetic Assay

Study Population 3

Description:

This study population will consist of individuals who are at high risk of developing breast cancer.

Treatment:

Other: Epigenetic Assay