Actively Recruiting
Biomarker Approach to Screening for the Early Detection of HPV-related Oropharyngeal Cancer (BASH OPC)
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-02-09
400
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a combined HPV 16 DNA and host gene methylation oral biomarker panel to distinguish early oropharyngeal cancer (OPC) cases from controls. The study aims to determine the sensitivity and specificity of this biomarker panel among 100 early and 100 late disease pre-treatment OPC cases, along with 200 matched controls. Participants are recruited from Moffitt Cancer Center and the University of Pittsburgh Medical Center Hillman Cancer Center to ensure geographic and demographic comparability. The study involves two groups: a case group of early and late disease pre-treatment OPC cases and a control group matched by sex, age, race/ethnicity, and tobacco use. The main intervention is a diagnostic test using the combined HPV 16 DNA and host gene methylation oral biomarker panel. Controls are enrolled from the surrounding area to match cases and ensure accurate comparisons. Participants will provide oral samples for DNA methylation profiling and HPV testing. Researchers will monitor diagnostic sensitivity and specificity over up to 60 months. Participants must provide informed consent and meet specific eligibility criteria. The study includes adults aged 18 and older, and participation involves no treatment but observation and biological sample collection to evaluate the biomarker's ability to detect early HPV-related oropharyngeal cancer.
CONDITIONS
Brief Title
Biomarker Approach to Screening for the Early Detection of HPV-related Oropharyngeal Cancer (BASH OPC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Have no previous diagnosis of head and neck cancer or HPV-related cancer
- Fully understands study procedures
- Voluntarily agrees to participate by giving written informed consent
You will not qualify if you...
- Not meeting all of the above inclusion criteria for either the case or control group
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 60 months
Participants undergo a combined HPV 16 DNA and host gene methylation oral biomarker panel test for early detection of HPV-related oropharyngeal cancer.
Visits as needed for diagnostic testing over the study period
Duration - Up to 60 months
Participants are monitored over time to assess diagnostic sensitivity and specificity of the biomarker panel.
Follow-up visits as scheduled during the study period
Trial Site Locations
Total: 2 locations
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
2
University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
Research Team
K
Kimberly Isaacs-Soriano
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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