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Biomarker Screening for HPV-Related Oropharyngeal Cancer

This study, called BASH OPC, is looking for a better way to find HPV-related oropharyngeal cancer (a type of throat cancer) early. Researchers are testing a combined HPV 16 DNA and host gene methylation oral biomarker panel. This panel is a diagnostic test that looks for specific markers in your mouth. The goal is to see how well this test can tell the difference between people with early or late-stage oropharyngeal cancer and people who don't have cancer. You can join if you are at least 18 years old and have newly diagnosed oropharyngeal cancer that hasn't been treated in the last four weeks, or if you are a healthy control. The study aims to enroll 400 participants. The study's success will be measured by how accurately this test identifies cancer (diagnostic sensitivity) and correctly identifies those without cancer (diagnostic specificity) over a period of up to 60 months.

Study design
This is an observational study, meaning researchers will observe participants without providing specific treatments. It plans to enroll 400 participants, including those with cancer and healthy controls.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 60 months to measure the diagnostic sensitivity and specificity of the test.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06305676

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

Recruiting
Not specifiedAges 18+Observational
H. Lee Moffitt Cancer Center and Research Institute
~400 participants
Updated 2026-02-09 on ClinicalTrials.gov
What's tested:combined HPV 16 DNA and host gene methylation oral biomarker panel

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Diagnostic Sensitivity
Measured over Up to 60 months
+1 more outcome measured

Conditions

Oropharyngeal Cancer
HPV-Related Carcinoma

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Oropharyngeal Carcinoma

NCT06305676

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Moffitt Cancer Center

    Tampa, Floridastudy coordinator listed

    Recruiting

  • University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center

    Pittsburgh, Pennsylvaniastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Anna Giuliano, PhD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center
  • Antonio Amelio, PhD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center

Who to contact

Kimberly Isaacs-Soriano
[email protected]
813-745-6992
Email the study team

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Eligibility criteria

Inclusion

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

What this trial measures

  • Diagnostic SensitivityUp to 60 months

    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.

  • Diagnostic SpecificityUp to 60 months

    A 95% one-sided confidence interval using the Wilson method will be obtained for Specificity based on the control patients.