Pilot Study of the Effect of Weight Loss on Breast Tissue and Blood Biomarkers in Women at Increased Risk for Breast Cancer
- Conditions
- Breast NeoplasmsObesity
- Interventions
- Procedure: BiopsyProcedure: Blood drawProcedure: MammogramProcedure: MRI
- Registration Number
- NCT02681120
- Lead Sponsor
- Tarah J Ballinger, MD
- Brief Summary
This is a pilot, non-randomized, single institution, observational study investigating the effect of dramatic weight loss secondary to bariatric surgery on biomarkers of breast cancer in tissue and blood as well as on imaging in women at elevated risk for breast cancer. Twelve months after bariatric surgery, 50% of excess weight is generally expected. Eligible women at elevated risk for breast cancer who are already planning to undergo bariatric surgery will be consented to undergo imaging (MRI and mammogram), breast tissue biopsy, and fasting blood draw prior to bariatric surgery, approximately 14 days after bariatric surgery, and approximately 1 year after bariatric surgery.
In parallel we will also be assessing 40 normal breast tissue specimens as well as blood samples from the Komen Tissue Bank (elevated risk but normal BMI) to establish a normal BMI, elevated risk control group for our study. The KTB samples will be matched for general risk of breast cancer (\>20%), age, race and menopausal status.
- Detailed Description
Primary Objectives
1. 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.
2. 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
3. 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.
4. 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.
5. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 3
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description High risk/BMI > 30 Biopsy Women at elevated risk for breast cancer will have imaging (MRI and mammogram) pre-bariatric surgery and 1 year post-bariatric surgery, and blood and tissue collection (blood draw and biopsy) pre-bariatric surgery, 2 weeks post-bariatric surgery, and 1 year post-bariatric surgery. High risk/BMI > 30 Blood draw Women at elevated risk for breast cancer will have imaging (MRI and mammogram) pre-bariatric surgery and 1 year post-bariatric surgery, and blood and tissue collection (blood draw and biopsy) pre-bariatric surgery, 2 weeks post-bariatric surgery, and 1 year post-bariatric surgery. High risk/BMI > 30 Mammogram Women at elevated risk for breast cancer will have imaging (MRI and mammogram) pre-bariatric surgery and 1 year post-bariatric surgery, and blood and tissue collection (blood draw and biopsy) pre-bariatric surgery, 2 weeks post-bariatric surgery, and 1 year post-bariatric surgery. High risk/BMI > 30 MRI Women at elevated risk for breast cancer will have imaging (MRI and mammogram) pre-bariatric surgery and 1 year post-bariatric surgery, and blood and tissue collection (blood draw and biopsy) pre-bariatric surgery, 2 weeks post-bariatric surgery, and 1 year post-bariatric surgery.
- Primary Outcome Measures
Name Time Method Change in breast density via MRI from baseline 1 year post-bariatric surgery Categorical measures will be reported numerically: 1-increased, 2-decreased, 3-no change
Change in breast density via mammography from baseline 1 year post-bariatric surgery Categorical measures will be reported numerically: 1-increased, 2-decreased, 3-no change
- Secondary Outcome Measures
Name Time Method Change in aromatase expression markers in obese tissue from baseline 1 year post-bariatric surgery Numerical measures
Comparison of number of crown-like structures in obese breast tissue and normal breast tissue 1 year post-bariatric surgery Numerical measures
Comparison of aromatase expression markers in normal weight breast tissue with obese breast tissue 1 year post-bariatric surgery Numerical measures
Change in other correlative blood markers (inflammatory, insulin, hormonal) from baseline 1 year post-bariatric surgery Numerical measures
Trial Locations
- Locations (3)
Indiana University Health North Hospital
🇺🇸Carmel, Indiana, United States
Indiana University Health Hospital
🇺🇸Indianapolis, Indiana, United States
Indiana University Melvin and Bren Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States