RecruitingObservational

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

NCT ID: NCT06305676Sponsor: H. Lee Moffitt Cancer Center and Research InstituteLast updated: 2026-02-09

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).

Arms & interventions

Diagnostic Testcombined HPV 16 DNA and host gene methylation oral biomarker panel
DNA Methylation Profiling

Outcome measures

Primary

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.
Time frame: Up to 60 months
Diagnostic Specificity
A 95% one-sided confidence interval using the Wilson method will be obtained for Specificity based on the control patients.
Time frame: Up to 60 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: Yes

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

Study locations (2)

Moffitt Cancer Center

Tampa, Florida, 33612

Recruiting

Kimberly Isaacs-Soriano · Contact

813-745-6992 kimberly.Isaacs-Soriano@moffitt.org

Anna Giuliano, PhD · Principal Investigator

Antonio Amelio, PhD · Principal Investigator

Jimmy Caudell, MD, PhD · Sub Investigator

Christine Chung, MD · Sub Investigator

Bruce Wenig, MD · Sub Investigator

University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

Recruiting

Jose P. Zevallos, MD, PhD · Contact

zevallosjp@upmc.edu

Robert Ferris, PhD · Contact

ferrrl@UPMC.EDU