Study to Validate Blood HPV DNA and Gene Mutations as Predictors of Recurrence in HPV-Positive Oropharyngeal Cancer

What this Trial Is About

Researchers are investigating whether the recurrence of HPV-associated oropharyngeal squamous cell carcinoma OPSCC can be predicted by specific genetic mutations and blood markers. The study focuses on mutations in the TRAF3 and CYLD genes and measurements of circulating HPV DNA in blood plasma. It also examines the relationship between HPV integration and these mutations to improve prediction of cancer recurrence. This observational study involves patients with p16 positive squamous cell carcinoma of the oropharynx or unknown primary who are planned to receive definitive cancer treatment. Participants are monitored without assigned treatments, as this study observes their condition and collects data over time. Participants will be followed for up to 5 years after their cancer therapy completion. During this time, researchers will assess recurrence through biopsy confirmation and imaging, monitor progression-free survival, and evaluate the predictive values of the biomarkers. Quality of life questionnaires will also be completed periodically until recurrence or the end of follow-up. The study aims to better understand how these biomarkers relate to disease outcomes.

Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC