An observational study in Triple Negative Breast Cancer, sponsored by University of Arizona. Withdrawn at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-20.
Sponsored by University of Arizona · Observational
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.
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.
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he overall strategy for this pilot project is to collect breast tissue from 30 non-tumor (control) subjects and 30 TNBC patients. The women will be stratified by BMI (lean, overweight, obese) and ethnicity (Hispanic vs NHW). Race and ethnicity will be self-reported. Hispanic women can be of any race. Due to the Southwestern location of the University of Arizona (UA) and the regional demographics, we expect that approximately 90% of the Hispanic women recruited for this study will be White of Mexican/Mexican-American ancestry. However, eligible non-White, Hispanic or non-Hispanic, subjects will not be excluded.
Exclusion Criteria:
Hispanic and NHW women undergoing either a benign breast surgery or prophylactic mastectomy.
Procedure: Needle core biopsy
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).
Procedure: 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.
Also known as: Blood draw
To determine if BMI/ obesity differentially influence expression and epigenetic signatures in TNBC from Hispanic compared to NHW women.
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.
Time frame: Two years
Plan to share: Undecided
No publications or documents are linked to this record.
This study is withdrawn, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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