Age-related variations: A retrospective analysis of 851 prospectively collected patient samples to determine the benefit of combining combinatorial protein biomarker assay for risk assessment in women with dense breast.

2015 ◽  
Vol 33 (28_suppl) ◽  
pp. 27-27
Author(s):  
David Emery Reese ◽  
Michael Silver ◽  
Meredith C. Henderson ◽  
Sherri Borman ◽  
Christa Corn ◽  
...  

27 Background: Clinicians often experience difficulty in differentiating benign lesions from invasive breast cancers in patients designated as dense breast. A major limitation of radiological breast cancer screening methods involves a decrease in sensitivity and specificity in women with dense breast. Thus, we sought to test whether Klarify Breast, a combinatorial protein-based biomarker panel could improve early detection of significant breast lesions in a controlled fashion. Clearly, a diagnostic assay that would provide biochemical evidence in the patient’s clinical course is greatly needed. Methods: We have conducted two independent, multi-center, prospective clinical trials to establish the clinical validity of Klarify Breast – an assay that uses multiple Serum Protein Biomarkers (SPBs), Tumor-Associated Autoantibodies (TAAbs), patient specific clinical data and develop a score to differentiate patients with benign breast disease from those with invasive breast cancer. Independent panels of biomarkers and associated algorithms were developed using prospectively collected samples from women under age 50 (n = 351) and from women ages 25-75 (n = 500). Here, we present the benefit of integrating the results of Klarify Breast test with patient imaging to best assess risk in women with dense breast. Results: While performance of the assay was somewhat age dependent (women under the age of 50 demonstrated a higher sensitivity and specificity than women over the age of 50). Here we present data that both groups of women clearly benefit from the addition of a biomarker assay combined with standard of care imaging in identifying invasive breast lesions. Conclusions: Clearly, in women with dense breast, where radiologic studies alone do not permit full assessment in women with a dense breast finding. The biomarker test here, comprised of TAAbs and SPBs, offers a clear advantage in terms of NPV, PPV, Sensitivity and specificity. The results argue strongly for the use of appropriate biomarkers to augment imaging based breast cancer screening in women with dense breast or those who are at high risk. Clinical trial information: NCT01839045, NCT02078570.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13586-e13586
Author(s):  
Richa Bansal ◽  
Bharat Aggarwal ◽  
Lakshmi Krishnan

e13586 Background: Screening mammography is often found to have low sensitivity in women with high density breast tissues. Alternate modalities of breast USG and MRI require high-quality expensive equipment making the regular screening with these modalities less affordable and accessible, particularly in resource-constrained settings This study evaluates the clinical performance of an AI-based test (Thermalytix) that uses machine learning on breast thermal images which could potentially be a low-cost solution for breast screening in low- and middle-income countries (LMICs). Methods: The prospective comparative study conducted from December 2018 to January 2020 evaluated the performance of Thermalytix in women with dense and non-dense breast tissue who presented for a health check-up at a hospital. All women underwent Thermalytix and mammography. Further investigations were recommended for participants who were reported as positive on either test. Sensitivity and specificity of Thermalytix were evaluated across age-groups, menopausal status, and breast densities. Results: Among the 687 women recruited for the study, 459 women who satisfied the inclusion criteria were included in the analysis. 168 women had ACR categories ‘c’ or ‘d’ dense breasts, of which 37 women had an inconclusive mammography report (BI-RADS 0). Overall, 21 women were detected with breast cancer in the study. Thermalytix demonstrated an overall sensitivity of 95.2% (95% CI, 76.1-99·9) and a specificity of 88.6% (95% CI, 85.2-91.4). Among women with dense breast tissue (n=168), Thermalytix showed a sensitivity of 100% (95% CI, 69.2-100) and a specificity of 81.7% (95% CI, 74.7-87.4). In women with ACR categories ‘c’ and ‘d’ dense breasts, mammography reported 22% of them as inconclusive (BI-RAD 0), while in the same sub-set of the population Thermalytix demonstrated a sensitivity of 100%. Conclusions: The AI-based Thermalytix demonstrated high sensitivity and specificity in the study cohort. It also fared well in women younger than 50 years and pre-menopausal women where routine mammography screening yields low sensitivity. Overall, this study introduces Thermalytix, a promising radiation-free, automated, and privacy-aware test that can supplement mammography for routine screening of women, especially in women with dense breast tissue, and has the potential to influence the clinical practice in LMICs by making breast cancer screening portable and affordable. Performance of Thermalytix and mammography in women with high breast densities (ACR categories ‘c’ and ‘d’ breasts). Clinical trial information: NCT04688086. [Table: see text]


QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Ghada Khaled Ahmed ◽  
Mounir Sobhy Guirguis ◽  
Mona Gamalluldin Alsayed Alkaphoury

Abstract Background Breast cancer remains one of the leading causes of death in women over the age of 40 years. Breast cancer screening is used to identify women with asymptomatic cancer with the goal of enabling women to undergo less invasive treatments that lead to better outcomes, ideally at earlier stages and before the cancer progresses. Mammography is the best-studied breast cancer screening modality and the only recommended imaging tool for screening the general population of women. Objective to correlate the relation between ACR density of breast and breast cancer in screening program. Patients and Methods Our study included 40 women of breast cancer were depicted radiologically and histo-pathologically diagnosed after outreaching for screening by Digital Mammography by the Egyptian National Breast Cancer Screening Program in Ain Shams University Hospitals at period from January 2018 to October 2019.Their data were collected from the medical records of the program. Their age ranged between 40 and 65 years. Results According to the BI-RADS 5th edition 2013, cases were classified into four classes as follows: 6 were ACR-A (15.0%), 21 were ACR-B (52.5%), 12 were ACR-C (30.0%) and 1 were ACR-D (2.5%), So according to our study results dense breast shouldn’t be considered as a risk factor for breast cancer as we observed that the percentage of breast cancer in our study increases the most with average breast density ACR class B then increases with ACR class C and A respectively. Conclusion dense breast is not a risk factor for breast cancer, so further researches are needed to study the relationship between breast density and breast cancer in Egyptian population, to elucidate the role of breast density estimation in prediction of breast cancer considering the genotypical and phenotypical differences of the Egyptian population.


2018 ◽  
Vol 21 ◽  
pp. S166
Author(s):  
JD Miller ◽  
MM Bonafede ◽  
SK Pohlman ◽  
KA Troeger

2018 ◽  
Vol 7 (9) ◽  
pp. 205846011879121 ◽  
Author(s):  
Georg J Wengert ◽  
Thomas H Helbich ◽  
Panagiotis Kapetas ◽  
Pascal AT Baltzer ◽  
Katja Pinker

Mammography, as the primary screening modality, has facilitated a substantial decrease in breast cancer-related mortality in the general population. However, the sensitivity of mammography for breast cancer detection is decreased in women with higher breast densities, which is an independent risk factor for breast cancer. With increasing public awareness of the implications of a high breast density, there is an increasing demand for supplemental screening in these patients. Yet, improvements in breast cancer detection with supplemental screening methods come at the expense of increased false-positives, recall rates, patient anxiety, and costs. Therefore, breast cancer screening practice must change from a general one-size-fits-all approach to a more personalized, risk-based one that is tailored to the individual woman’s risk, personal beliefs, and preferences, while accounting for cost, potential harm, and benefits. This overview will provide an overview of the available breast density assessment modalities, the current breast density screening recommendations for women at average risk of breast cancer, and supplemental methods for breast cancer screening. In addition, we will provide a look at the possibilities for a risk-adapted breast cancer screening.


2016 ◽  
Vol 207 (2) ◽  
pp. 450-457 ◽  
Author(s):  
Robin B. Shermis ◽  
Keith D. Wilson ◽  
Malcolm T. Doyle ◽  
Tamara S. Martin ◽  
Dawn Merryman ◽  
...  

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