Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
80

Summary

Conditions
  • Breast Neoplasms
  • Obesity
Type
Observational
Design
Observational Model: Case-ControlTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 75 years
Gender
Only males

Description

Primary Objectives The effect of bariatric surgery on Background Parenchymal Enhancement (BPE) on breast MRI through comparative analysis of images of women pre- and 1 year post-bariatric surgery. The effect of bariatric surgery on breast density as seen on standard four view mammograms by qualitati...

Primary Objectives The effect of bariatric surgery on Background Parenchymal Enhancement (BPE) on breast MRI through comparative analysis of images of women pre- and 1 year post-bariatric surgery. The effect of bariatric surgery on breast density as seen on standard four view mammograms by qualitative BIRADS category through comparative analysis of images of women pre- and 1 year post-bariatric surgery. Secondary Objectives The impact of bariatric surgery on obesity associated immune markers in breast tissue by: Comparing cellular immune infiltrate components [B cells (CD 20), cytotoxic T cells (CD8), helper T cells (CD4), dendritic cells (CD11c), leukocytes (CD45), and monocytes/macrophages (CD68)] in breast tissue lobules of obese women pre-, 14 days post, and 1 year post bariatric surgery, and comparing these to normal breast tissue of lean women from the KTB Comparing the presence of crown like structures (CLS) in breast tissue of obese women at pre-, 14 day post-, and 1 year post - bariatric surgery, and comparing these also to normal breast tissue of lean women from the KTB. The effect of bariatric surgery on aromatase expression in breast tissue of obese women pre-, 14 day post-, and 1 year post-bariatric surgery, as compared to levels in breast tissue of lean women from KTB. The effects of bariatric surgery on other blood correlatives pre- and 14 day and 1 year post-bariatric surgery including: 1) PGE2, TNF alpha, IL1 beta, IL-8 and IL-10 in the inflammatory pathway; 2) adiponectin, leptin, insulin, IGF1, and IGFBP3 in the insulin pathway; and 3) estradiol, SHBG, E2, T and DHEAS in the hormonal pathway. These will also be compared to blood samples from lean women in the KTB.

Tracking Information

NCT #
NCT02681120
Collaborators
Not Provided
Investigators
Principal Investigator: Tarah Ballinger, MD Indiana University School of Medicine, Indiana University Simon Cancer Center