Epigenetics of TNBC in Overweight and Obese Hispanic & Non-Hispanic White Women
Epigenetics of Triple-Negative Breast Cancer in Overweight and Obese Hispanic and Non-Hispanic White Women
A key tenet of this project is that of reaching translational human diagnosis and biomarker end points. To lay a foundation and make progress towards these translational goals, investigators will address the following specific aim:
To determine if BMI/ obesity differentially influence expression and epigenetic signatures in triple negative breast cancer (TNBC) from Hispanic compared to NHW women.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Contacts and Locations
Study Locations
-
-
Arizona
-
Tucson, Arizona, United States, 85724
- University of Arizona Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Control group
Hispanic and NHW women undergoing either a benign breast surgery or prophylactic mastectomy.
|
Blood draws will be done in OR by research staff. Tissue will be obtained at the time of their definitive surgery or at the time of port placement. For women going to surgery first, four (4) 16-gauge core needle biopsies will be obtained by research staff after the tumor has been removed from the patient and the specimen is on the collection table in the OR. For women who are getting neo-adjuvant therapy prior to surgery, the core needle biopsies will be collected at the time of port placement in the OR. The patient will be under light anesthesia for the port placement. Per standard care, we will also use local anesthetic for the needle core biopsy. Port placement requires ultrasound (US). We will take advantage of the US already available in the OR to guide the core needle biopsy. Within 30 minutes of procurement, the tissue from the biopsies will be flash frozen in liquid nitrogen by staff and taken to the lab.
Other Names:
|
|
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).
|
Blood draws will be done in OR by research staff. Tissue will be obtained at the time of their definitive surgery or at the time of port placement. For women going to surgery first, four (4) 16-gauge core needle biopsies will be obtained by research staff after the tumor has been removed from the patient and the specimen is on the collection table in the OR. For women who are getting neo-adjuvant therapy prior to surgery, the core needle biopsies will be collected at the time of port placement in the OR. The patient will be under light anesthesia for the port placement. Per standard care, we will also use local anesthetic for the needle core biopsy. Port placement requires ultrasound (US). We will take advantage of the US already available in the OR to guide the core needle biopsy. Within 30 minutes of procurement, the tissue from the biopsies will be flash frozen in liquid nitrogen by staff and taken to the lab.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To determine if BMI/ obesity differentially influence expression and epigenetic signatures in TNBC from Hispanic compared to NHW women.
Time Frame: Two years
|
DXA studies will be completed prior to surgery or port placement. Blood draws will be done in OR by research staff. Tissue will be obtained at the time of their definitive surgery or at the time of port placement. For women going to surgery first, four (4) 16-gauge core needle biopsies will be obtained by research staff after the tumor has been removed from the patient and the specimen is on the collection table in the OR. For women who are getting neo-adjuvant therapy prior to surgery, the core needle biopsies will be collected at the time of port placement in the OR. |
Two years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2001272738
- 32097 (Other Identifier: University of Arizona Cancer Center)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.