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Recruiting NCT06305676

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

— Observational Oropharyngeal Cancer HPV-Related Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: combined HPV 16 DNA and host gene methylation oral biomarker panel.
Who it may be relevant to
Registry conditions: Oropharyngeal Cancer, HPV-Related Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

  • Diagnostic test combined HPV 16 DNA and host gene methylation oral biomarker panel
    DNA Methylation Profiling

Primary outcome measures

  • Diagnostic Sensitivity [Time frame: Up to 60 months]
  • Diagnostic Specificity [Time frame: Up to 60 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 2 centers
  • Moffitt Cancer Center — Tampa
  • University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center — Pittsburgh

Identifiers

NCT: NCT06305676 · MCC-23073

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗