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

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

Plain Language Summary

Simplified for easier understanding

This study is developing and testing blood-based biomarkers — measurable biological signals in the bloodstream — that could help detect HPV-related throat cancer (oropharyngeal cancer) earlier, before it becomes more advanced. **You may be eligible if...** - You are 18 years or older - You have been newly diagnosed with squamous cell cancer of the throat (oropharynx), stages I–IV, confirmed by biopsy - You have not yet received treatment (surgery, chemotherapy, radiation, or immunotherapy) in the past 4 weeks - OR you are a healthy person aged 35 or older with no history of head and neck cancer or HPV-related cancer who is willing to serve as a comparison participant **You may NOT be eligible if...** - You have already started cancer treatment - You have a previous history of head and neck cancer (for healthy participants) - You do not meet the study site's consent and enrollment requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTcombined HPV 16 DNA and host gene methylation oral biomarker panel

DNA Methylation Profiling


Locations(2)

Moffitt Cancer Center

Tampa, Florida, United States

University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06305676


Related Trials