Effects of Bariatric Surgery on Breast Density Improvement and Impact on Breast Cancer Risk in Severe Obese Patients

September 14, 2023 updated by: Raul Rosenthal, The Cleveland Clinic

Effects of Bariatric Surgery on Breast Density Improvement and Its Impact on Breast Cancer Risk in Morbidly Obese Patients

Breast cancer is the most common cancer in women in the US, and obese women have a 20% to 40% increase in the risk of developing breast cancer compared with normal-weight women. Bariatric surgery is now considered the first line option for weight loss management in morbidly obese patients with failure of medical treatment.

There is strong evidence that in early stages of cancer the breast undergoes inflammatory and subsequently density changes that are observable in mammography. The aforementioned alterations have been suggested to be magnified by obesity, potentially due to its pro-inflammatory state. The investigators hypothesized that rapid weight loss following bariatric surgery and henceforth the reduction of inflammatory stress in the breast tissue could potentially have a positive effect in improving breast density and consequently, reducing the risk of breast cancer. In this order of ideas, with this study, the investigators aim to evaluate how breast density is modified after bariatric surgery, and how it impacts the risk of developing breast cancer using The Breast Cancer Surveillance Consortium (BCSC) risk score and calculator in our population.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective observational study involving patients selected for elective bariatric surgery. Thirty-five women older than age 40 and younger than age 74 undergoing primary bariatric surgery and having a BMI of ≥35 will be enrolled in this study. Patients with previous diagnosis of breast cancer, previous diagnosis of ductal carcinoma in situ (DCIS), previous breast augmentation and previous mastectomy will be excluded from the study. Patients selected and consented for elective bariatric surgery will be recruited in the Bariatric and Metabolic Institute at CCF, Weston FL and will undergo standard of care and additional measurements before and after surgery as explained below:

  • A first mammogram study will be performed between two to four weeks before bariatric surgery, if the patient had a normal digital mammogram performed in the 12 months prior to bariatric surgery, it would be accepted as the first mammogram study. This mammogram is a part of the standard of care screening for this population group. Standard measurements will be assessed including the BI-RADS® breast density score (radiologic assessment of the density of breast tissue by a radiologist who interprets mammograms) and The LIBRA (Laboratory for Individualized Breast Radiodensity Assessment) software.
  • A subsequent mammogram study (also part of the standard of care screening for this population group) will be performed one year after the date of the bariatric procedure, and standard measurements will be re-assessed, including re-stratification of BI-RADS and LIBRA.
  • The mammogram results will be obtained through medical records. If a patient had done a mammogram at a non Cleveland Clinic facility, the investigator will ask them to sign an authorization form to allow Cleveland Clinic Florida to request for their mammography study from the previous year to the outside facility where it was done.
  • Inflammatory markers including CRP, IGF1, IL6, TNF, will also be measured between two to four weeks before bariatric surgery as a part of the pre-surgical blood work up and, one year after the date of the bariatric procedure.

The inflammatory markers will be collected and processed as follows:

  • CRP will be collected in a test tube containing lithium heparin (Green container). It will be delivered between two hours of collection to our institutional laboratory for processing.
  • IGF1 will be collected in a test tube containing SST (Gold container). It will be delivered refrigerated between two hours of collection to our institutional laboratory for processing.
  • IL6 will be collected in a test tube containing SST (Gold container). It will be delivered on ice ASAP upon collection to our institutional laboratory for processing.

  • TNF will be collected in a test tube containing SST (Gold container). It will be delivered between two hours of collection to our institutional laboratory for processing.

    • Biometric measurements will be assessed before surgery and at the time of the subsequent mammogram (one year after surgery). It will include weight, height, BMI and Waist circumference.
    • Basic demographics and comorbidities (Diabetes Mellitus, Hypertension, pulmonary hypertension, sleep apnea, dyslipidemia, cardiovascular disease, chronic kidney disease, smoking status, alcohol use and hormonal replacement history) will also be analyzed.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Emanuele Lo Menzo, MD
  • Phone Number: 9546595232
  • Email: lomenze@ccf.org

Study Locations

  • United States
    • Florida
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women older than age 40 and younger than age 74 undergoing primary bariatric surgery selected and consented for elective bariatric surgery will be recruited

Description

Inclusion Criteria:

  • women older than age 40 and younger than age 74 who qualify for bariatric surgery (BMI of ≥35 with at least one co-morbid condition), or BMI> 40

Exclusion Criteria:

  • Patients with previous diagnosis of breast cancer, previous diagnosis of ductal carcinoma in situ (DCIS), previous breast augmentation and previous mastectomy will be excluded from the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bariatric surgery group
Women older than age 40 and younger than age 74 undergoing primary bariatric surgery and having a BMI of ≥35 will be enrolled in this study. Pre operative and postoperative mammograms, inflammatory markers and breast cancer risk scores will be compared.
Procedure: Bariatric surgery
Patients selected and consented for elective bariatric surgery will undergo standard of care preoperative mammogram, as well as inflammatory markers measurements and breast cancer risk score calculation. Post bariatric surgery the patients will have follow up mammogram, inflammatory markers, and breast cancer risk score calculation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mammogram findings before and after intervention: BI-RADS
Time Frame: 12 months
Mammogram findings according to the BI-RADS® breast density score (radiologic assessment of the density of breast tissue
12 months
Mammogram findings before and after intervention:LIBRA
Time Frame: 12 months
Mammogram findings according to the The LIBRA (Laboratory for Individualized Breast Radiodensity Assessment) software
12 months
Inflammatory markers before and after intervention: C-reactive protein
Time Frame: 12 months
Serum measurements of Inflammatory marker including C-reactive protein (CRP)
12 months
Inflammatory markers before and after intervention: Interleukin-6
Time Frame: 12 months
Serum measurements of Inflammatory marker including Interleukin-6 (IL-6)
12 months
Inflammatory markers before and after intervention: Insulin Growth Factor-1 (IGF-1)
Time Frame: 12 months
Serum measurements of Inflammatory marker including Insulin Growth Factor-1 (IGF-1)
12 months
Inflammatory markers before and after intervention: Tumor Necrosis
Time Frame: 12 months
Serum measurements of Inflammatory marker including Tumor Necrosis Factor (TNF)
12 months
Breast cancer risk calculation
Time Frame: 12 months
Breast cancer risk calculation using The Breast Cancer Surveillance Consortium (BCSC) Risk Calculator
12 months
Biometric measurements: weight
Time Frame: 12 months
Weight will be assessed before surgery and at one year after surgery.
12 months
Biometric measurements: Height
Time Frame: 12 months
Height will be assessed before surgery and at one year after surgery.
12 months
Biometric measurements: Body mass index
Time Frame: 12 months
Body mass index will be assessed before surgery and at one year after surgery.
12 months
Biometric measurements: Waist circumference.
Time Frame: 12 months
Waist circumference. will be assessed before surgery and at one year after surgery.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Raul Rosenthal, MD, Cleveland Clinic Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2021

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

November 18, 2019

First Submitted That Met QC Criteria

November 18, 2019

First Posted (Actual)

November 20, 2019

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

September 14, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLA 18-057

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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