Clinical trial · Observational
Effects of Bariatric Surgery on Breast Density Improvement and Impact on Breast Cancer Risk in Severe Obese Patients
Effects of Bariatric Surgery on Breast Density Improvement and Its Impact on Breast Cancer Risk in Morbidly Obese Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No inclusion
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bariatric Surgery Candidate | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Morbid Obesity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bariatric surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Bariatric surgery group
- description
- 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.
- interventionNames
- Procedure: Bariatric surgery
Primary outcomes (11)
- measure
- Mammogram findings before and after intervention: BI-RADS
- timeFrame
- 12 months
- description
- Mammogram findings according to the BI-RADS® breast density score (radiologic assessment of the density of breast tissue
- measure
- Mammogram findings before and after intervention:LIBRA
- timeFrame
- 12 months
- description
- Mammogram findings according to the The LIBRA (Laboratory for Individualized Breast Radiodensity Assessment) software
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDSteele 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 28981482
- BACKGROUNDVaysse 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 28884144
- BACKGROUNDSun 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 28077158
- BACKGROUNDMcCormack 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 16775176
- BACKGROUNDWilliams 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 28660430
- BACKGROUNDKeller 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.