RecruitingNCT06305676

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

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

400 participants

Start Date

Jan 22, 2024

Study Type

OBSERVATIONAL

Conditions

Oropharyngeal Cancer HPV-Related Carcinoma

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).

Eligibility

Min Age: 18 Years

Inclusion Criteria9

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