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

Recruiting

• Conditions: Oropharyngeal Cancer; HPV-Related Carcinoma

• 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

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)

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

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