Study of a Combined HPV 16 DNA and Gene Methylation Test for Early Detection of HPV-Related Oropharyngeal Cancer

What this Trial Is About

Researchers are evaluating a combined HPV 16 DNA and host gene methylation oral biomarker panel to distinguish early oropharyngeal cancer OPC cases from controls. The study aims to determine the sensitivity and specificity of this biomarker panel among 100 early and 100 late disease pre-treatment OPC cases, along with 200 matched controls. Participants are recruited from Moffitt Cancer Center and the University of Pittsburgh Medical Center Hillman Cancer Center to ensure geographic and demographic comparability. The study involves two groups a case group of early and late disease pre-treatment OPC cases and a control group matched by sex, age, raceethnicity, and tobacco use. The main intervention is a diagnostic test using the combined HPV 16 DNA and host gene methylation oral biomarker panel. Controls are enrolled from the surrounding area to match cases and ensure accurate comparisons. Participants will provide oral samples for DNA methylation profiling and HPV testing. Researchers will monitor diagnostic sensitivity and specificity over up to 60 months. Participants must provide informed consent and meet specific eligibility criteria. The study includes adults aged 18 and older, and participation involves no treatment but observation and biological sample collection to evaluate the biomarkers ability to detect early HPV-related oropharyngeal cancer.

Biomarker Approach to Screening for the Early Detection of HPV-related Oropharyngeal Cancer (BASH OPC)