BC-DETECT: combined detection of serum HE4 and TFF3 improves breast cancer diagnostic efficacy

Background: The incidence and mortality of breast cancer are increasing annually. Breast cancer seriously threatens women's health and quality of life. We aimed to measure the clinical value of CPN1, a new serum marker of breast cancer and to evaluate the efficacy of CPN1 in combination with CA15-3. Methods: Seventy samples of breast cancer with lymph node metastasis, seventy-three samples of nonmetastatic breast cancer and twenty-five samples of healthy human serum were collected. Serum CA15-3 concentration was determined by Roche Elecsys, and serum CPN1 concentration was determined by ELISA. Results: In breast cancer patients, serum CPN1 concentration was positively correlated with tumour size, clinical stage and CA15-3 concentration (r = 0.376, P<0.0001). ROC curve analysis showed that the optimal critical concentration of CPN1 for breast cancer diagnosis was 32.8pg/ml. The optimal critical concentration of CPN1 in the diagnosis of metastatic breast cancer was 66.121pg/ml. CPN1 has a greater diagnostic ability for breast cancer (AUCCA15-3=0.702 vs. AUCCPN1=0.886, P<0.0001) and metastatic breast cancer (AUCCA15-3=0.629 vs. AUCCPN1=0.887, P<0.0001) than CA15-3, and the combined detection of CA15-3 and CPN1 can improve the diagnostic efficiency for breast cancer (AUCCA15-3+CPN1=0.916) and for distinguishing between metastatic and non-metastatic breast cancer (AUCCA15-3+CPN1=0.895). Conclusion: CPN1 can be used as a new tumour marker to diagnose and evaluate the invasion and metastasis of breast cancer. The combined detection of CPN1 and CA15-3 is more accurate and has a certain value in clinical application.

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A multicenter, hospital-based and non-inferiority study for diagnostic efficacy of automated whole breast ultrasound for breast cancer in China

Scientific Reports ◽

10.1038/s41598-021-93350-1 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Yujing Xin ◽

Xinyuan Zhang ◽

Yi Yang ◽

Yi Chen ◽

Yanan Wang ◽

...

Keyword(s):

Breast Cancer ◽

False Negative ◽

Final Analysis ◽

Age Group ◽

Surgical Biopsy ◽

True Negative ◽

Diagnostic Efficacy ◽

Negative Results ◽

Informed Consent Form ◽

Magnetic Resonance Imaging Mri

AbstractThis study is the first multi-center non-inferiority study that aims to critically evaluate the effectiveness of HHUS/ABUS in China breast cancer detection. This was a multicenter hospital-based study. Five hospitals participated in this study. Women (30–69 years old) with defined criteria were invited for breast examination by HHUS, ABUS or/and mammography. For BI-RADS category 3, an additional magnetic resonance imaging (MRI) test was provided to distinguish the true negative results from false negative results. For women classified as BI-RADS category 4 or 5, either core aspiration biopsy or surgical biopsy was done to confirm the diagnosis. Between February 2016 and March 2017, 2844 women signed the informed consent form, and 1947 of them involved in final analysis (680 were 30 to 39 years old, 1267 were 40 to 69 years old).For all participants, ABUS sensitivity (91.81%) compared with HHUS sensitivity (94.70%) with non-inferior Z tests, P = 0.015. In the 40–69 age group, non-inferior Z tests showed that ABUS sensitivity (93.01%) was non-inferior to MG sensitivity (86.02%) with P < 0.001 and HHUS sensitivity (95.44%) was non-inferior to MG sensitivity (86.02%) with P < 0.001. Sensitivity of ABUS and HHUS are all superior to that of MG with P < 0.001 by superior test.For all participants, ABUS specificity (92.89%) was non-inferior to HHUS specificity (89.36%) with P < 0.001. Superiority test show that specificity of ABUS was superior to that of HHUS with P < 0.001. In the 40–69 age group, ABUS specificity (92.86%) was non-inferior to MG specificity (91.68%) with P < 0.001 and HHUS specificity (89.55%) was non-inferior to MG specificity (91.68%) with P < 0.001. ABUS is not superior to MG with P = 0.114 by superior test. The sensitivity of ABUS/HHUS is superior to that of MG. The specificity of ABUS/HHUS is non-inferior to that of MG. In China, for an experienced US radiologist, both HHUS and ABUS have better diagnostic efficacy than MG in symptomatic individuals.

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