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

Recruiting

• Conditions: Oropharyngeal Cancer; HPV-Related Carcinoma
• Interventions: Diagnostic Test: combined HPV 16 DNA and host gene methylation oral biomarker panel

• Registration Number: NCT06305676
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-22
• Study First Submitted: 2024-03-06
• Study First Submitted QC: 2024-03-06
• Study First Posted: 2024-03-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-18
• Primary Completion: 2029-01
• Study Completion: 2029-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case Group	combined HPV 16 DNA and host gene methylation oral biomarker panel	Case group will consist of early and late disease pre-treatment Oropharyngeal Cancer cases.
Control Group	combined HPV 16 DNA and host gene methylation oral biomarker panel	Controls will be enrolled from members of the catchment area to ensure geographic comparability of cases and controls. Controls will be matched by sex, age, race/ethnicity, and tobacco use.

Primary Outcome Measures

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

Trial Locations

Locations (2)

University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States