Biomarker Approach to Screening for the Early Detection of HPV-related Oropharyngeal Cancer (BASH OPC)
- Oropharyngeal Cancer
- HPV-Related Carcinoma
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Enrolment target
- 400
- Started
- 22 January 2024
- Main results due
- January 2029
- Study sites
- 3
- Registry updated
- 23 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- Healthy volunteers can take part.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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
What this study is about
In the sponsor’s own words, from the registry.
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).
Study sites(3)
Moffitt Cancer Center
Tampa, Florida, United States
Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, United States
Recruiting
University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Recruiting
Showing 3 of 3 sites. 3 of the 3 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06305676. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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