Immune Biomarker Study for Head and Neck Cancer Prognostic Immune Signatures and Tumor Organoid Analysis A Prospective Observational Multicenter Trial

What this Trial Is About

Researchers are studying the role of immune biomarkers both within tumors and in the bloodstream for people newly diagnosed with non-metastatic head and neck cancers such as squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, paranasal sinuses, or larynx. The goal is to understand how local immune activity in tumors relates to systemic immune status, to identify immune patterns that could help predict outcomes and guide future personalized treatments. This observational trial aims to create a prognostic score based on clusters of tumor immune characteristics. Participants include those with newly diagnosed head and neck squamous cell carcinoma in specific stages, as well as a control group of patients without cancer undergoing surgery. Blood, saliva, stool, and tumor tissue samples will be collected at various points, including before surgery, shortly after surgery, and during or after radiotherapy or immunotherapy. Tumor organoids will be grown outside the body for further biological analysis. During the study, patients will have multiple blood draws and other sample collections to monitor immune cell types, cytokines, gene activity, metabolic and microbiomic states over time, up to five years after treatment. Researchers will observe changes in the immune environment from before surgery through the end of radiotherapy and beyond. This long-term monitoring aims to correlate immune changes with patient outcomes and improve understanding of tumor-immune interactions.

Immune Biomarker Study for Head and Neck Cancer