NCT06305676RecruitingAccepts Healthy Volunteers
Biomarker Approach to Screening for the Early Detection of HPV-related Oropharyngeal Cancer (BASH OPC)
H. Lee Moffitt Cancer Center and Research Institute
Start Date
1/22/2024
Completion Date
1/1/2029
Summary
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).
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
Cases:
* 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
* Aged at least 35 years
* Have no previous diagnosis of HNC or HPV-related cancer
* Fully understands study procedures
* Voluntarily agrees to participate by giving written informed consent under Moffitt Cancer Center (MCC) 17716 biomarker/biobanking study or is enrolled at the University of Pittsburgh Medical Center Hillman Cancer Center
Exclusion Criteria:
* Not meeting all of the above inclusion criteria for either the case or control group
Interventions
DIAGNOSTIC_TEST
combined HPV 16 DNA and host gene methylation oral biomarker panel
Conditions
Oropharyngeal CancerHPV-Related Carcinoma
Locations
Moffitt Cancer Center
Tampa, Florida 33612
United States
University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United States