Abstract P1-02-10: Early stage breast cancer screening using an emerging novel liquid biopsy screening technology
Authors: Liu C , Dou J , Sheng Y , Wu J , Hu W , Li Y , Lin Y , Tao H , Tang X , Du X , Yu C 
Published: May 2019

Abstract
Background: An emerging novel liquid biopsy technology called Cancer Differentiation Analysis (CDA) has been evaluated as a viable early stage breast cancer screening tool. CDA technology is a blood-sample based, multi-level, multi-parameter diagnostic method which detects signals from both protein, cellular, and to some extent, molecular levels, in which multiple aspects of information can be collected to improve diagnostic accuracy, even for early stage of cancer. Improving capability to screen breast cancer is an important on-going research effort, as breast cancer represents a leading cancer with high incidence rate.
Methods: In this single-blind study, 22 breast cancer patients and 25 healthy individuals were recruited at Changhai Hospital of Shanghai. Histopathological examination results of breast cancer patients were collected, 22 cases were diagnosed as infiltrating ductal carcinoma of breast, of which 10 patients were stage I breast cancer. 25 individuals were confirmed healthy after physical examinations. Peripheral blood was drawn in EDTA tubes For CDA tests. CDA data of 22 breast cancer patients and 25 healthy individuals were conducted using SPSS, and the results were shown in the table below.
Results: The average CDA of breast cancer, stageIbreast cancer, and controls were 43.20, 44.17 and 36.17 (rel. units) respectively as shown in Table 1. Both breast cancer and stage I breast cancer could be significantly distinguished from the control (p = 0.000, p = 0.001, respectively). For stage I breast cancer vs. control group, Area under ROC curve was 0.876, sensitivity and specificity were both 80.0% (Table 2). In contrast to traditional breast cancer screening methodologies which have relatively low sensitivity and high false positives for stage I detection, often with radiation side effects and high costs, advantages of CDA technology include ability to detect early stage cancer with relatively high sensitivity and specificity, and it is also highly cost effective without side effects.
Conclusions: Initial results showed that CDA technology could effectively distinguish stageIbreast cancer from healthy individuals, CDA could be a potential candidate for breast cancer screening.
Table 1Summary of CDA test resultsGroupSample SizeAge RangeAge MeanAge MedianCDA Mean (rel. units)CDA Median (rel. units)CDA STDEVControl2523 - 67413735.6336.176.98Breast Cancer2239 - 78545343.2042.304.18Stage I Breast Cancer1043 - 78595944.1743.254.29Stage II Breast Cancer839 - 55474941.2840.303.06Stage III Breast Cancer255555542.2042.202.12Stage IV Breast Cancer251 - 64585847.0047.007.78
Table 2AUC, Sensitivity and Specificity of Control vs. Stage I breast cancerStage I Breast Cancer vs. ControlArea Under the CurveSensitivitySpecificity 0.87680.0%80.0%
Citation Format: Liu C, Dou J, Sheng Y, Wu J, Hu W, Li Y, Lin Y, Tao H, Tang X, Du X, Yu C. Early stage breast cancer screening using an emerging novel liquid biopsy screening technology [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P1-02-10.