Development and Validation of a Biopsy Decision Model for Nasopharyngeal Carcinoma Based on Serological Markers and Endoscopic Features

An observational study combines retrospective and prospective cohorts to develop, validate, and compare models based on Epstein-Barr virus (EBV)-related blood biomarkers alone, nasopharyngeal endoscopic scores alone, and their combination to support biopsy decisions for nasopharyngeal carcinoma (NPC). Existing clinical data will be analyzed retrospectively for model development and internal validation. Data from participants undergoing nasopharyngeal endoscopy and clinically indicated nasopharyngeal biopsy at participating centers will be collected prospectively for external validation. The study will assess the models' diagnostic performance and potential value in identifying individuals who may benefit from biopsy and reducing unnecessary biopsies. Clinical decisions will follow routine practice.

Inclusion Criteria: 1. Voluntarily agree to participate in the study and provide written informed consent; 2. Be aged ≥18 years; 3. Have available EBV-related serological test results or be able to provide blood samples for the relevant testing; 4. Undergo nasopharyngeal endoscopy for nasopharyngeal carcinoma risk assessment or suspected nasopharyngeal carcinoma; 5. Undergo nasopharyngeal biopsy as part of routine clinical care. Exclusion Criteria: 1. Previous confirmed diagnosis of nasopharyngeal carcinoma or prior treatment for nasopharyngeal carcinoma; 2. Receipt of immunosuppressive therapy or other treatments that may affect serum antibody levels within the past 6 months; 3. Severe organ dysfunction, including decompensated heart failure, respiratory failure, decompensated liver cirrhosis, or renal failure.