Epigenetics of TNBC in Overweight and Obese Hispanic & Non-Hispanic White Women

NCT04291950 | Withdrawn DMC

• 2 other identifiers: 200127273832097
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Triple Negative Breast Cancer

Keywords

triple negative; breast cancer; TNBC; obesity; overweight; Hispanic; non-Hispanic white

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control group

Hispanic and NHW women undergoing either a benign breast surgery or prophylactic mastectomy.

Procedure: Needle core biopsy

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).

Procedure: Needle core biopsy

Interventions

Needle core biopsy PROCEDURE

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

Control group; Newly diagnosed TNBC

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Four (4) 16-gauge core needle biopsies of breast tissue. Ten (10) ml of blood

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Breast Neoplasms; Obesity; Overweight

Interventions

Biopsy, Needle; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Study Officials

• Pavani Chalasani, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 2, 2020
• Study Start: August 30, 2022
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: December 20, 2022

Record last verified: 2022-12

Locations

US (1)