Predicting Cancer Risk in Oral Leukoplakia Using a MAGE-A Immunoscore A Study on Early Detection and Monitoring of Oral Precancerous Lesions

What this Trial Is About

Oral squamous cell carcinoma OSCC is a common cancer worldwide, often developing from oral leukoplakia OLP, a precancerous lesion. This research aims to study the expression of MAGE-A antigens as a marker to predict the risk of OLP turning into OSCC. The study also explores the connection between MAGE-A expression and changes in the immune environment, which may lead to new immunotherapy options for OLP. The study is prospective and multicenter, focusing on improving early detection and treatment strategies for OLP to reduce OSCC morbidity and mortality. Participants diagnosed with OLP will undergo routine photo documentation and biopsy of the lesion. The biopsy tissue will be split one part fixed for routine histology and the other preserved for molecular analysis of MAGE-A expression. The standard clinical treatment will be followed based on histological findings, with lesions showing higher risk treated surgically or by laser. The study includes a follow-up period of at least three years, with evaluations at two and three years, and plans to extend monitoring to five years to observe any malignant transformations. Participants will be monitored through clinical visits, with biopsy results and analyses performed at a central lab. The study tracks the presence of MAGE-A as a potential predictive marker alongside traditional histology. Researchers will assess how well MAGE-A predicts malignant transformation and study immune changes in lesions. The main outcome is measuring malignant transformation related to MAGE-A expression over two, three, and five years. This study may lead to new diagnostic and treatment methods for OLP patients.

Prediction of Malignant Transformation of Oral Leukoplakia Using a MAGE-A-based Immunoscore