Epigenetics of TNBC in Overweight and Obese Hispanic & Non-Hispanic White Women
NCT ID: NCT04291950
Last Updated: 2022-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2022-08-30
2025-08-30
Brief Summary
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To determine if BMI/ obesity differentially influence expression and epigenetic signatures in triple negative breast cancer (TNBC) from Hispanic compared to NHW women.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Control group
Hispanic and NHW women undergoing either a benign breast surgery or prophylactic mastectomy.
Needle core biopsy
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.
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).
Needle core biopsy
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.
Interventions
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Needle core biopsy
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ≥ 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
* 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
18 Years
FEMALE
Yes
Sponsors
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University of Arizona
OTHER
Responsible Party
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Principal Investigators
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Pavani Chalasani, MD
Role: PRINCIPAL_INVESTIGATOR
University of Arizona
Locations
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University of Arizona Cancer Center
Tucson, Arizona, United States
Countries
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Other Identifiers
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32097
Identifier Type: OTHER
Identifier Source: secondary_id
2001272738
Identifier Type: -
Identifier Source: org_study_id