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Biomarker Approach to Screening for the Early Detection of HPV-related Oropharyngeal Cancer (BASH OPC)
Who can join
Ages 18 and older · All sexes · Healthy volunteers welcome
Full eligibility criteria
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
About the study
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).
What is being tested
- combined HPV 16 DNA and host gene methylation oral biomarker panel (diagnostic test)
Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Participants: 400 · Started: Jan 22, 2024
Contact the study team
- Kimberly Isaacs-Soriano · Phone: 813-745-6992
Official record on ClinicalTrials.gov — NCT06305676
Locations in the U.S.
| Florida | Moffitt Cancer Center, Tampa |
| Nebraska | University of Nebraska Medical Center, Omaha |
| Pennsylvania | University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center, Pittsburgh |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.