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Clinical Trial 17716

Cancer Type: Head & Neck

Study Type: Other
Phase of Study: N/A

  • Anna Giuliano

Call 813-745-6100
or 1-800-679-0775

Study Title

A Biomarker-related Approach to Screening for HPV-related Oropharyngeal Cancer


This is a questionnaire and oral mucosal sample study. The data obtained from this study will help develop new screening tests for oropharyngeal cancers. We hope to identify markers that can be detected in an oral gargle sample to screen for oropharyngeal cancer in the future. Men will be recruited from the Head and Neck Cancer Program clinic at the Moffitt Cancer Center.


1. Recruit and enroll a cohort of 150 OPC cases prior to treatment from the Moffitt Head and Neck Cancer Program a. Implement a short risk factor questionnaire b. Collect an oral gargle and sponge specimen c. Obtain the biopsy/tumor block for HPV and biomarker assessment 2. Estimate prevalence of the following markers from the oral gargle and sponge specimen and tumor block: a. HPV genotype (DNA) b. immunological factors (SLPI, oral cytokine profile) c. HPV viral factors (e.g., HPV L1 methylation, variants, and integration status) d. p16 expression (marker of HPV-mediated cell deregulation) 3. Assess concordance between markers detected in tumor and oral gargle specimens among OPC cases

Inclusion Criteria

  • Men, ages 18 years and older
  • Diagnosis of cancer of the oropharynx, Stages I-IV
  • Fully understands study procedures, risks involved in the study, and voluntarily agrees to participate by giving written informed consent