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 Nebraska Medical Center
Omaha, Nebraska 68198
United States
University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United States