Biomarker Approach to Screening for the early detection of HPV- related Oropharyngeal Cancer (BASH OPC)
Categories (click each to see list of all clinical trials associated with that category): Cancer Prevention and Control (ONC)
Current Status: Open
Phase: N/A (Cancer Control) (Cancer Prevention)
Principal Investigator: Dickey, Brittney
Contact Information:
Jordyn Rockwell
jorockwell@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT06305676?term=NCT06305676&rank=1#participation-criteria
Summary
Primary Aim: Estimate the sensitivity and specificity of a combined HPV 16 DNA and host gene methylation oral biomarker panel to distinguish early OPC cases from controls among 100 early and 100 late disease pre-treatment OPC cases, and 200 controls matched by sex, age, race, and tobacco use collected from the Moffitt Cancer Center (Moffitt), the University of Pittsburgh Medical Center Hillman Cancer Center (UPMC), and the University of Nebraska Medical Center (UNMC).
Secondary Aims:
1. Assess the oral gargle methylation assay and HPV 16 detection concordance between laboratories and reliability within each laboratory (across different days).
2. Assess factors (e.g., sex, race, age, tobacco use, oral health) associated with the oral gargle biomarker panel levels among controls and separately among OPC cases.
3. Assess performance of other differentially methylated host genes (e.g., SYNGR312) and/or TTMV HPV DNA measured in oral samples to detect OPC early.