Enhancing the Diagnostic Performance of Early Lung Cancer by Integrating Multiplex Nucleic Acid Aptamer Detection With Conventional Tumor Markers: A Prospective Observational Study.

[OBJECTIVES] To evaluate the value of incorporating multiplex nucleic acid aptamer detection into conventional serum tumor marker testing for improving the early diagnosis of lung cancer.

[METHODS] This prospective observational study enrolled 158 participants, including patients with pathologically confirmed lung cancer (n=82), individuals with benign pulmonary lesions (n=26), and healthy controls (n=50). Serum levels of 5 conventional tumor markers, neuron-specific enolase (NSE), carcinoembryonic antigen (CEA), squamous cell carcinoma antigen (SCCAg), pro-gastrin-releasing peptide (ProGRP), and cytokeratin 19 fragment 21-1 (CYFRA21-1) were examined. Nucleic acid aptamer signals (ΔCt values and positivity rates) were measured in all participants. A conventional model, an aptamer-based model, and a combined model integrating both approaches were constructed. Diagnostic performance for early lung cancer was compared using receiver operating characteristic (ROC) curve analysis.

[RESULTS] Serum levels of all 5 conventional tumor markers and nucleic acid aptamer signals differed significantly among the 3 groups. For lung cancer diagnosis, the combined model (conventional tumor markers plus nucleic acid aptamer detection) demonstrated higher area under the ROC curve (AUC), sensitivity, and specificity than the conventional model alone. In diagnosing early lung cancer, the combined model achieved the best discriminative performance. The combined model improved discrimination and reclassification for early lung cancer.

[CONCLUSIONS] Integrating nucleic acid aptamer detection with conventional tumor marker testing enhances the diagnostic accuracy and discriminative ability for early lung cancer. The incremental value of this combined approach suggests a potential optimized strategy for early lung cancer detection.