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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute

About this trial

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

Qualifiers

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

Disqualifiers

Not meeting all of the above inclusion criteria for either the case or control group

Trial design

Treatments tested in this trial

  • combined HPV 16 DNA and host gene methylation oral biomarker panel

Treatment groups

400 Participants
are divided into 2 treatment groups

Locations

2
Moffitt Cancer Center33612, TampaFlorida, United States
University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center15232, PittsburghPennsylvania, United States

Sponsors and collaborators

H. Lee Moffitt Cancer Center and Research Institute

Lead sponsor

National Institutes of Health (NIH)

Collaborator