What type of study is this?

This is a Case-Control Study study.

October 12, 2025Open Access

Potential of Serum ApoC1 as a Noninvasive Biomarker for Breast Cancer Detection and Prognosis: A Prospective Case–Control Study

AKAbolfazl Khalafi‐NezhadShiraz University of Medical Sciences MBMahdi BarazeshGerash University of Medical Sciences AAAhmad AbdollahiGerash University of Medical Sciences

Key Points

ApoC1 concentrations were significantly lower in breast cancer patients compared to healthy controls.
The study achieved 100% sensitivity, specificity, and accuracy for diagnosing breast cancer using ApoC1 levels.
ROC curve analysis confirmed ApoC1 as a promising biomarker with optimal cutoff values indicating excellent diagnostic performance.
HER2 over-expression in breast cancer patients showed a significant difference in ApoC1 levels, enhancing its prognostic value.

Abstract

ABSTRACT Background and Aims Breast cancer (BC) is one of the most frequent malignancies. Apolipoprotein C1 (ApoC1) has been known as a promising therapeutic target and valuable prognostic and diagnostic biomarker in cancers. The aim of this study was to explore the diagnostic implication of serum ApoC1 concentration in new cases of BC. Methods This prospective case–control study was conducted on 76 new cases of BC patients referred to Amir‐al‐Momenin Gerash hospital. Subjects in the control group were 15 healthy individuals. The serum concentrations of ApoC1 of the control group and the BC patients were measured by ELISA assay. Data analysis was performed using Student's t ‐test and one‐way analysis of variance (ANOVA) followed by Dunnett's post hoc test. Results The mean age of the BC patients was 49.21 ± 10.42 years. In terms of diagnostic performance, ApoC1 concentration showed a significant down‐regulation in female BC patients compared to healthy controls. The receiver operating characteristic (ROC) curve analysis indicated an area under the curve (AUC) of 1.00, demonstrating the excellent diagnostic value of ApoC1 in distinguishing BC patients from healthy individuals. The optimal cutoff value for ApoC1 concentration was determined to be 15.4 mg/dL, with 100% sensitivity, 100% specificity, and 100% accuracy. Furthermore, the prognostic analysis focused on HER2 over‐expression patients demonstrated a statistically significant difference in ApoC1 concentration compared to other types of BC. The ROC curve analysis revealed the prognostic performance of ApoC1, with an optimal cutoff value of 5.6 mg/dL, 100% positive predictive value (PPV), and 100% negative predictive value (NPV). Conclusion According to the findings of the current study, ApoC1 may be a potential serum biomarker for the diagnosis of BC. Moreover, ApoC1 can be considered a highly accurate prognostic biomarker for BC.

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