NCT04170335

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2019

Completed
1.3 years until next milestone

Study Start

First participant enrolled

February 22, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

2.8 years

First QC Date

November 18, 2019

Last Update Submit

September 14, 2023

Conditions

Breast CancerMorbid ObesityBariatric Surgery Candidate

Keywords

Breast cancerMorbid obesityBariatric surgeryMammographyInflammatory markers

Outcome Measures

Primary Outcomes (11)

  • Mammogram findings before and after intervention: BI-RADS

    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

    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

    Serum measurements of Inflammatory marker including C-reactive protein (CRP)

    12 months

  • Inflammatory markers before and after intervention: Interleukin-6

    Serum measurements of Inflammatory marker including Interleukin-6 (IL-6)

    12 months

  • Inflammatory markers before and after intervention: Insulin Growth Factor-1 (IGF-1)

    Serum measurements of Inflammatory marker including Insulin Growth Factor-1 (IGF-1)

    12 months

  • Inflammatory markers before and after intervention: Tumor Necrosis

    Serum measurements of Inflammatory marker including Tumor Necrosis Factor (TNF)

    12 months

  • Breast cancer risk calculation

    Breast cancer risk calculation using The Breast Cancer Surveillance Consortium (BCSC) Risk Calculator

    12 months

  • Biometric measurements: weight

    Weight will be assessed before surgery and at one year after surgery.

    12 months

  • Biometric measurements: Height

    Height will be assessed before surgery and at one year after surgery.

    12 months

  • Biometric measurements: Body mass index

    Body mass index will be assessed before surgery and at one year after surgery.

    12 months

  • Biometric measurements: Waist circumference.

    Waist circumference. will be assessed before surgery and at one year after surgery.

    12 months

Study Arms (1)

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

Interventions

Bariatric surgeryPROCEDURE

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

Bariatric surgery group

Eligibility Criteria

Age40 Years - 74 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Related Publications (7)

  • Steele CB, Thomas CC, Henley SJ, Massetti GM, Galuska DA, Agurs-Collins T, Puckett M, Richardson LC. Vital Signs: Trends in Incidence of Cancers Associated with Overweight and Obesity - United States, 2005-2014. MMWR Morb Mortal Wkly Rep. 2017 Oct 3;66(39):1052-1058. doi: 10.15585/mmwr.mm6639e1.

    PMID: 28981482BACKGROUND

  • Vaysse C, Lomo J, Garred O, Fjeldheim F, Lofteroed T, Schlichting E, McTiernan A, Frydenberg H, Husoy A, Lundgren S, Fagerland MW, Richardsen E, Wist EA, Muller C, Thune I. Erratum: Inflammation of mammary adipose tissue occurs in overweight and obese patients exhibiting early-stage breast cancer. NPJ Breast Cancer. 2017 Sep 5;3:35. doi: 10.1038/s41523-017-0030-x. eCollection 2017.

    PMID: 28884144BACKGROUND

  • Sun X, Glynn DJ, Hodson LJ, Huo C, Britt K, Thompson EW, Woolford L, Evdokiou A, Pollard JW, Robertson SA, Ingman WV. CCL2-driven inflammation increases mammary gland stromal density and cancer susceptibility in a transgenic mouse model. Breast Cancer Res. 2017 Jan 11;19(1):4. doi: 10.1186/s13058-016-0796-z.

    PMID: 28077158BACKGROUND

  • McCormack VA, dos Santos Silva I. Breast density and parenchymal patterns as markers of breast cancer risk: a meta-analysis. Cancer Epidemiol Biomarkers Prev. 2006 Jun;15(6):1159-69. doi: 10.1158/1055-9965.EPI-06-0034.

    PMID: 16775176BACKGROUND

  • Williams AD, So A, Synnestvedt M, Tewksbury CM, Kontos D, Hsiehm MK, Pantalone L, Conant EF, Schnall M, Dumon K, Williams N, Tchou J. Mammographic breast density decreases after bariatric surgery. Breast Cancer Res Treat. 2017 Oct;165(3):565-572. doi: 10.1007/s10549-017-4361-y. Epub 2017 Jun 28.

    PMID: 28660430BACKGROUND

  • Keller BM, Chen J, Daye D, Conant EF, Kontos D. Preliminary evaluation of the publicly available Laboratory for Breast Radiodensity Assessment (LIBRA) software tool: comparison of fully automated area and volumetric density measures in a case-control study with digital mammography. Breast Cancer Res. 2015 Aug 25;17:117. doi: 10.1186/s13058-015-0626-8.

    PMID: 26303303BACKGROUND

  • Schauer DP, Feigelson HS, Koebnick C, Caan B, Weinmann S, Leonard AC, Powers JD, Yenumula PR, Arterburn DE. Bariatric Surgery and the Risk of Cancer in a Large Multisite Cohort. Ann Surg. 2019 Jan;269(1):95-101. doi: 10.1097/SLA.0000000000002525.

    PMID: 28938270BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsObesity, Morbid

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Raul Rosenthal, MD

    Cleveland Clinic Florida

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman Department of Surgery

Study Record Dates

First Submitted

November 18, 2019

First Posted

November 20, 2019

Study Start

February 22, 2021

Primary Completion

December 1, 2023

Study Completion

December 31, 2023

Last Updated

September 15, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)