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Background <p>A Cholangiocarcinoma (CCA) is highly aggressive malignancy. It accounts for roughly 3% of all gastrointestinal cancers and 10% of all primary hepatobiliary malignancies. The incidence rate of hepatocellular carcinoma (HCC) has doubled in the past decade, indicating an increasing burden of the disease in Egypt. Apurinic/Apyrimidinic endodeoxyribonuclease 1 (APEX1) is the main endonuclease that participates in the base excision repair mechanism in response to DNA damage, and it is expressed across various human tissues. Dysregulated expression of APEX1 may impair various physiological functions.</p> Objectives <p>The current study aims to assess serum APEX1 levels as diagnostic biomarkers for CCA and HCC in contrast to conventional tumor markers.</p> Subjects and methods <p>The study included 171 subjects, comprising 40 healthy volunteers selected from a blood donation unit, 47 patients with CCA, 40 cases with benign biliary disorders (BBD), and 44 cases with HCC. All research participants had their APEX1 levels assessed using the enzyme-linked immunosorbent Assay (ELISA).</p> Results <p>Results indicate that APEX1 levels exhibited significant variation (<i>p</i> &lt; 0.001) across the studied cohorts. APEX1 levels were significantly reduced in the BBD and control groups, with median levels measuring 0.74 and 0.76 pg/ml, Min-Max measuring (0.21 – 1.80), (0.23 – 2.40) pg/ml, respectively. In contrast, the CCA cohort exhibited the highest levels, a median of 7.78 pg/ml, a Min- Max (0.44 – 21.70) pg/ml followed by the HCC cohort at 3.2 pg/ml with Min-Max (0.45 – 13.60) pg/ml. APEX1 demonstrated a sensitivity of 88.89% and a specificity of 83.33% at a cutoff value of 1.04 pg/mL, as determined through ROC curve analysis for differentiating CCA from healthy controls. At a cutoff value of 1.14 pg/ml, the diagnostic performance of APEX1 levels in differentiating HCC cases from healthy controls demonstrated a sensitivity of 87.18% and a specificity of 86.67%. However, it failed to distinguish HCC from CCA (<i>p</i> &gt; 0.05, AUC 0.614).</p> Conclusion <p>Serum APEX1 represents a promising diagnostic biomarker for both CCA and HCC, but with less performance than other markers except for differentiating CCA from BBD it showed exhibiting superior specificity to CA 19.9 APEX1 levels in CCA cases are significantly correlated with the number of focal lesions and lymph node metastases; however, they do not effectively distinguish CCA from HCC cases.</p>

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Evaluation of serum Apurinic/Apyrimidinic Endodeoxyribonuclease 1 (APEX1) Level in cholangiocarcinoma and hepatocellular carcinoma patients

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月26日

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  • Ahmed Ahmed El-Shaarawy,
  • Gamal Youssef Abo Raya,
  • Eman Abdelsameea,
  • Eman Said Hamed Meselhy,
  • Mona Gamal El-Abd,
  • Mai I. ELAshmawy

摘要

Background

A Cholangiocarcinoma (CCA) is highly aggressive malignancy. It accounts for roughly 3% of all gastrointestinal cancers and 10% of all primary hepatobiliary malignancies. The incidence rate of hepatocellular carcinoma (HCC) has doubled in the past decade, indicating an increasing burden of the disease in Egypt. Apurinic/Apyrimidinic endodeoxyribonuclease 1 (APEX1) is the main endonuclease that participates in the base excision repair mechanism in response to DNA damage, and it is expressed across various human tissues. Dysregulated expression of APEX1 may impair various physiological functions.

Objectives

The current study aims to assess serum APEX1 levels as diagnostic biomarkers for CCA and HCC in contrast to conventional tumor markers.

Subjects and methods

The study included 171 subjects, comprising 40 healthy volunteers selected from a blood donation unit, 47 patients with CCA, 40 cases with benign biliary disorders (BBD), and 44 cases with HCC. All research participants had their APEX1 levels assessed using the enzyme-linked immunosorbent Assay (ELISA).

Results

Results indicate that APEX1 levels exhibited significant variation (p < 0.001) across the studied cohorts. APEX1 levels were significantly reduced in the BBD and control groups, with median levels measuring 0.74 and 0.76 pg/ml, Min-Max measuring (0.21 – 1.80), (0.23 – 2.40) pg/ml, respectively. In contrast, the CCA cohort exhibited the highest levels, a median of 7.78 pg/ml, a Min- Max (0.44 – 21.70) pg/ml followed by the HCC cohort at 3.2 pg/ml with Min-Max (0.45 – 13.60) pg/ml. APEX1 demonstrated a sensitivity of 88.89% and a specificity of 83.33% at a cutoff value of 1.04 pg/mL, as determined through ROC curve analysis for differentiating CCA from healthy controls. At a cutoff value of 1.14 pg/ml, the diagnostic performance of APEX1 levels in differentiating HCC cases from healthy controls demonstrated a sensitivity of 87.18% and a specificity of 86.67%. However, it failed to distinguish HCC from CCA (p > 0.05, AUC 0.614).

Conclusion

Serum APEX1 represents a promising diagnostic biomarker for both CCA and HCC, but with less performance than other markers except for differentiating CCA from BBD it showed exhibiting superior specificity to CA 19.9 APEX1 levels in CCA cases are significantly correlated with the number of focal lesions and lymph node metastases; however, they do not effectively distinguish CCA from HCC cases.