Early Detection and Longitudinal Follow-Up of Non-Invasive Biomarkers for Laryngeal Squamous Cell Carcinoma: First Results of the BEAL-Study.

INTRODUCTION: Despite therapeutic and prognostic improvements in the early treatment of laryngeal squamous cell carcinoma (LSCC), screening for early detection of laryngeal cancer has not yet been established. METHODS: A study has been designed to address this issue based on an analysis of exosomal serum biomarkers for LSCC. A three-step approach was used. Firstly, the serum biomarkers Nov and uPAR were validated in control and LSCC patients using a standardized enzyme-linked immunosorbent assay (ELISA). Subsequently, an immunohistochemical comparison was conducted. Secondly, the ELISA results were compared with patients with benign laryngeal lesions. Thirdly, a prospective study compared preoperative and postoperative values. The study is ongoing. RESULTS: In the initial comparison of the control group with tumor patients at the time of diagnosis, Nov and uPAR demonstrated significant overexpression in LSCC patients' serum. In Step 2, the comparison with the cohort of benign laryngeal lesions revealed that both biomarkers were also significantly overexpressed here. Nevertheless, uPAR effectively differentiated between control, benign, and malignant lesions. In the third step, the observations in the postoperative course demonstrated that the serum concentrations of Nov and uPAR were elevated in both groups with laryngeal diseases but declined faster in patients with benign lesions. CONCLUSION: uPAR and Nov may serve as valuable biomarkers for early detection and disease monitoring. Further investigation is required to ascertain their suitability, including an extended follow-up period and a larger study population. For this reason, this study is still ongoing, and only initial results are presented here. This study's objective is to examine the potential of Nov and uPAR as serum biomarkers for early detection and follow-up of LSCC. We compare them in a control group, tumor group, and first-time benign laryngeal diseases and monitor a long-term follow-up. This aims to deepen understanding of suitability for early detection and follow-up and provide future research insights. TRIAL REGISTRATION: DRKS00033427.