Investigators seek to determine the sensitivity and specificity of a combined HPV 16 DNA and host gene methylation oral biomarker panel to distinguish early Oropharyngeal Cancer (OPC) cases from controls among 100 early and 100 late disease pre-treatment OPC cases, and 200 controls matched by sex, age, race/ethnicity, and tobacco use collected from the Moffitt Cancer Center (Moffitt) and the University of Pittsburgh Medical Center Hillman Cancer Center (Pittsburgh).
Aged at least 18 years
Newly diagnosed primary tumor, histologically confirmed squamous cell carcinoma of the oropharynx (stages I-IV)
Has not received treatment (surgery, chemotherapy, radiation, or immunotherapy) within the previous four weeks
Provided written informed consent under Moffitt Cancer Center (MCC) 17716 biomarker/biobanking study or is identified and enrolled at the University of Pittsburgh Medical Center Hillman Cancer Center
Not meeting all of the above inclusion criteria for either the case or control group
The study population will consist of 100 early and 100 late disease pre-treatment Oropharyngeal Cancer cases, and 200 controls matched by sex, age, race/ethnicity, and tobacco use collected from the Moffitt Cancer Center (Moffitt) and the University of Pittsburgh Medical Center Hillman Cancer Center (Pittsburgh).
Case-control
Prospective
combined HPV 16 DNA and host gene methylation oral biomarker panel
Diagnostic testDNA Methylation Profiling
Diagnostic Sensitivity
A 95% one-sided confidence interval using the Wilson method will be obtained for sensitivity for the early Oropharyngeal Cancer cases and late Oropharyngeal Cancer cases.
Diagnostic Specificity
A 95% one-sided confidence interval using the Wilson method will be obtained for Specificity based on the control patients.
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H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
National Institutes of Health (NIH)
Collaborator
