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NCT06305676Recruiting

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

Source: ClinicalTrials.gov · Last updated 23 Sept 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Study type
Observational
Enrollment
400 (estimated)
First submitted
6 Mar 2024
Start date
22 Jan 2024
Primary completion date
Jan 2029
Lead sponsor
H. Lee Moffitt Cancer Center and Research Institute
NCT number
NCT06305676

What you commit to

  • Study type: Observational
  • Planned participants: 400
  • From 22 Jan 2024 to the primary completion date, Jan 2029
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Not meeting all of the above inclusion criteria for either the case or control group

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Nebraska Medical Center
Coordinator of this site? Confirm its status
OmahaUnited StatesRecruiting
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
Coordinator of this site? Confirm its status
PittsburghUnited StatesRecruiting
Moffitt Cancer Center
Coordinator of this site? Confirm its status
TampaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.