Developing an Original Biomarker Panel for Early Detection of Oral Premalignant Lesions in Nigerian Patients

Early detection of oral potentially malignant disorders prevents malignant transformation and significantly improves oral cancer outcomes, and developing an original non-invasive salivary biomarker panel optimised for detection in Nigerian clinical settings represents a significant translational contribution to dental oncology. This study developed and validated an original salivary biomarker panel for early detection of oral potentially malignant disorders in Nigerian patients. A multi-phase study was conducted at the Oral Medicine and Oral and Maxillofacial Surgery departments of University of Nigeria Teaching Hospital Enugu and Lagos University Teaching Hospital. Phase 1 profiled salivary proteomics using LC-MS/MS in 30 OPMD patients, 30 OSCC patients, and 30 healthy controls. Phase 2 validated candidate biomarkers using ELISA in an independent cohort of 120 patients. IL-8, MMP-9, transferrin, and beta-2 microglobulin were identified as the highest-performing panel candidates in Phase 1. In Phase 2 validation, the four-biomarker panel achieved an AUC of 0.91 for OPMD detection (sensitivity 84.4 percent, specificity 88.3 percent). IL-8 alone had AUC of 0.79 for OPMD. Panel performance was superior to conventional oral examination alone. Inter-institution biomarker level variation was modest and within acceptable clinical ranges. The original biomarker panel constitutes a significant translational contribution. Recommendations include a large-scale prospective validation in a phase 3 clinical trial across multiple Nigerian centres, development of a point-of-care immunoassay format, and regulatory pathway planning with NAFDAC.

Keywords: oral potentially malignant disorders, salivary biomarkers, early detection, oral cancer, Nigeria