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Background HE4 is expressed in most lung adenocarcinomas and in a significant number of squamous, small cell and large cell carcinomas of the lung, suggesting that it could be used as a diagnostic and/or prognostic factor to refine the standard pathologic analysis. Methodology Data was collected prospectively in the form of blood sample withdrawn from patients with NSCLC confirmed with pathology presented to bronchogenic clinic in Oncology department of Ain Shams University in pretreatment state &amp; from healthy controls with matched age &amp; sex. The Human HE4 (Epididymal Protein 4) was measured in serum samples using Enzyme linked immunosorbent assay [ELISA], the assay was performed using Human HE4 9Epididymal protein 4) ELISA kit, cat no: EH0365 (Fine Test, Wuhan Fine Biotech Co., China). Results 77 patients with NSCLC cases &amp; 30 healthy controls were enrolled in the study. Serum HE4 showed to have to a diagnostic tendency were its value in NSCLC cases was from 42 to 130 pmol/l (median= 72pmol/l). but in controls its value was from 10 to 67 pmol/l (median = 35 pmol/l), which was highly statistically significant (P = 0.001). The cut off value of serum HE4 was 60 pmol/l with sensitivity 77% &amp; specificity 96% (95% CI 0.9-1). Serum HE4 showed to be a poor prognostic marker to OS with statistically significant difference were those with pretreatment serum HE4&amp;lt; 72 pmol/l mean survival time 17.6 months in comparison to the group with pretreatment serum HE4 &amp;gt; 72pmol/l mean survival time 13.2 months (p = 0.02). Conclusion There is a negative correlation between Serum HE4 in NSCLC &amp; overall survival, the highest the serum level the shortest the survival. This result can present serum HE4 as a novel prognostic &amp; probably diagnostic marker for NSCLC.

Prospective Analysis of Serum HE4 as an Independent Prognostic Factor in Non Small Cell Lung Cancer