Serum PLAC1 levels for differential diagnosis between cervical intraepithelial neoplasia and invasive cervical cancer: a prospective observational study
摘要
Reliable blood-based biomarkers for distinguishing invasive cervical cancer (ICC) from cervical intraepithelial neoplasia (CIN) remain limited. Placenta-specific protein 1 (PLAC1), a protein normally restricted to placental tissue, has been implicated in tumorigenesis. This prospective observational study enrolled 213 women who underwent colposcopy and biopsy at our hospital between January 2022 and February 2025. Participants were classified as CIN or ICC based on histopathology. Peripheral venous blood samples were collected before any cervical lesion-related treatment, and serum PLAC1 levels were measured using enzyme-linked immunosorbent assay. A total of 122 patients with CIN and 91 patients with ICC were included. HPV16/18 positivity was notably higher in ICC than in CIN. Serum PLAC1 levels were significantly higher in patients with CIN2–3 than in those with CIN1 and were further elevated in patients with ICC. SCC-Ag levels were also significantly higher in ICC than in CIN, whereas CEA and CA125 showed no meaningful differences between groups. Among patients with ICC, serum PLAC1 levels also increased across microinvasive, locally invasive, and advanced-stage subgroups. ROC curve analysis showed that PLAC1 had diagnostic value for distinguishing ICC from CIN, with an AUC of 0.815, a sensitivity of 73.6%, and a specificity of 70.5%. Multivariable analysis further showed that serum PLAC1 remained independently associated with ICC after adjustment for clinical variables. These findings indicate that serum PLAC1 is elevated in ICC and has potential value as a blood-based biomarker for differentiating malignant cervical disease from precancerous lesions, although further validation in larger cohorts is needed.