Sponsor study identifier
Secondary identifiers
OTHER · University of Arizona Cancer Center
observational
0
1 country
1
Study Start
August 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
August 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 27, 2020
Actual (reported)March 2, 2020
Actual (reported)August 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Two years
Hispanic and NHW women undergoing either a benign breast surgery or prophylactic mastectomy.
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.
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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.
University of Arizona Cancer Center
Tucson, Arizona, 85724, United States
Four (4) 16-gauge core needle biopsies of breast tissue. Ten (10) ml of blood
Pavani Chalasani, MD
University of Arizona
0 participants (actual enrollment reported by the registry).
First Submitted
February 27, 2020
First Posted
March 2, 2020
Study Start
August 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
OCTANE: Adjuvant Liposomal Doxorubicin and Carboplatin for Early-stage Triple-negative Breast Cancer
Contact the study team to confirm eligibility.
Primary Completion
August 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 20, 2022
Record last verified: 2022-12
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Source: ClinicalTrials.gov.
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