Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-02-26 @ 5:45 PM
Study NCT ID:
NCT04170335
Status:
WITHDRAWN
Last Update Posted:
2023-09-15
First Post:
2019-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Bariatric Surgery on Breast Density Improvement and Impact on Breast Cancer Risk in Severe Obese Patients
Sponsor:
The Cleveland Clinic
Organization:
Study Overview
Official Title:
Effects of Bariatric Surgery on Breast Density Improvement and Its Impact on Breast Cancer Risk in Morbidly Obese Patients
Status:
WITHDRAWN
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No inclusion
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: