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

H. Lee Moffitt Cancer Center and Research Institute

Status: Enrolling

Conditions: HPV-Related Carcinoma; Oropharyngeal Cancer

Treatments: Diagnostic Test: combined HPV 16 DNA and host gene methylation oral biomarker panel

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT06305676

MCC-23073

Details and patient eligibility

About

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).

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

400 participants in 2 patient groups

Case Group

Description:

Case group will consist of early and late disease pre-treatment Oropharyngeal Cancer cases.

Treatment:

Diagnostic Test: combined HPV 16 DNA and host gene methylation oral biomarker panel

Control Group

Description:

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.

Treatment:

Diagnostic Test: combined HPV 16 DNA and host gene methylation oral biomarker panel