Pilot Study of the Effect of Weight Loss on Breast Tissue and Blood Biomarkers in Women at Increased Risk for Breast Cancer
NCT ID: NCT02681120
Last Updated: 2021-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
3 participants
OBSERVATIONAL
2016-10-07
2020-01-30
Brief Summary
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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
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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High risk/BMI > 30
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.
Biopsy
Blood draw
Mammogram
MRI
Women with normal BMI
Deidentified samples that were donated to the IU Komen Tissue Bank will be used for comparison to the high risk/BMI \> 30 cohort.
No interventions assigned to this group
Interventions
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Biopsy
Blood draw
Mammogram
MRI
Eligibility Criteria
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Inclusion Criteria
1. Age over 60
2. Prior oophorectomy
3. No menstrual periods in the past 12 months without a medical procedure such as hysterectomy or uterine ablation
4. FSH at castrate levels (\> 40IU/L). Patients who do not meet criteria a-c (such as those under age 60 with prior hysterectomy but ovaries remain in place) will need to have an FSH level to confirm menopausal status prior to enrollment.
2. Patients must have a BMI ≥ 30 as calculated by the formula:
Weight in pounds / height squared x 703 = BMI
A BMI of:
1. 18.5-24.9 is considered normal;
2. 25.0-29.9 is considered overweight;
3. 30.0+ is regarded as obese.
3. Patients must be planning to undergo primary bariatric surgery (no revisions).
4. Patients must be willing to provide a core tissue biopsy at baseline and with repeat tissue collection after 2 weeks and 12 months post-bariatric surgery.
5. Patients must be aged 18-75 years at the time of informed consent.
6. Patients must be accessible for treatment, adverse event tracking and follow-up as determined by the treating physician.
7. Patient consent and authorization for the release of health information must be obtained according to local institutional guidelines.
Exclusion Criteria
2. Concurrent or planned participation in randomized trials of weight loss or exercise interventions or trials targeting insulin, IGF-1 or their receptors. These interventions would interfere with the endpoints.
3. Weight greater than 500 lbs at the time of imaging.
4. Known allergy to gadolinium which is used for MRI contrast.
5. History of life threatening allergic reaction to local anesthesia (lidocaine, xylocaine).
6. For the purposes of invasive breast biopsies, women must not have received therapeutic anticoagulation in the 1 month prior to enrollment, and must have no medical reason why post-operative prophylactic anticoagulation could be held for 12 hours (i.e. atrial fibrillation, history of deep venous thrombosis).
7. Prior history of breast irradiation.
8. Use of chemopreventatives such as tamoxifen or raloxifene at any time prior to enrollment.
18 Years
75 Years
FEMALE
No
Sponsors
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Tarah J Ballinger, MD
OTHER
Responsible Party
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Tarah J Ballinger, MD
Professor of Clinical Medicine
Principal Investigators
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Tarah Ballinger, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University School of Medicine, Indiana University Simon Cancer Center
Locations
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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
Countries
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Other Identifiers
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1511957605
Identifier Type: OTHER
Identifier Source: secondary_id
IUSCC-0556
Identifier Type: -
Identifier Source: org_study_id