Epigenetics of TNBC in Overweight and Obese Hispanic & Non-Hispanic White Women
Keywords
Abstract
Description
The intended goal of this Project is to develop epigenetic biomarkers to monitor the role of obesity and ethnicity on he development of triple negative breast cancer (TNBC). The proposed approach will seek to clarify for the first time if BMI is a biological factor that regulates aromatic hydrocarbon receptor (AhR) expression and epigenetic activity at breast cancer susceptibility and hormone receptor genes based on Hispanic or non-Hispanic white (NHW) ethnicity. If successful, the proposed experiments have the potential to highlight the role of overweight and obesity for dietary prevention of TNBC and to underscore the consideration of breast cancer screening among overweight/obese Hispanic women. Additionally, this study will provide the opportunity to begin testing the utility of AhR as a biomarker of TNBC development related to BMI and ethnicity.
Dates
| Last Verified: | 05/31/2020 |
| First Submitted: | 02/26/2020 |
| Estimated Enrollment Submitted: | 02/26/2020 |
| First Posted: | 03/01/2020 |
| Last Update Submitted: | 05/31/2020 |
| Last Update Posted: | 06/03/2020 |
| Actual Study Start Date: | 07/14/2020 |
| Estimated Primary Completion Date: | 08/31/2021 |
| Estimated Study Completion Date: | 08/31/2021 |
Condition or disease
Intervention/treatment
Procedure: Needle core biopsy
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Control group Hispanic and NHW women undergoing either a benign breast surgery or prophylactic mastectomy. | |
| Newly diagnosed TNBC Hispanic and NHW with newly diagnosed TNBC. Patients with TNBC will be eligible regardless of whether their treatment plan is surgery first or chemotherapy first (neoadjuvant chemotherapy). |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | Female |
| Sampling method | Non-Probability Sample |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Hispanic or NHW women - ≥ 18 years of age - scheduled for a breast procedure as standard of care treatment - benign breast surgery or prophylactic mastectomy\ - Newly diagnosed TNBC - Patients with TNBC will be eligible regardless of whether their treatment plan is surgery first or chemotherapy first (neoadjuvant chemotherapy) - Eligible non-white women could be included Exclusion Criteria: - BRCA1/2 mutation carriers - Family history of breast cancer in a first-degree relative and have NOT had genetic testing for BRCA1/2 - Patients who have already undergone radiation or chemotherapy - Pregnant women - Male - Prisoners |
Outcome
Primary Outcome Measures
1. To determine if BMI/ obesity differentially influence expression and epigenetic signatures in TNBC from Hispanic compared to NHW women. [Two years]
