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  • Cancer Type: Head & Neck
  • Study Type: Other
  • NCT#:
  • Phase: N/A
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  • Overview

    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 900 newly diagnosed OPC patients prior to treatment from Moffitt Cancer Center Outpatient Clinics. Enrollment will include 820 men and 80 women. a. Implement a short risk factor questionnaire b. Collect oral rinse, saliva sample (1 time pre-treatment specimen collection), and blood specimens prior to treatment, 4 weeks into radiation treatment, immediately after completion of radiation treatment, and at the 3-month follow up visit post completion of treatment. c. Obtain the pre-treatment biopsy/tumor block for HPV and biomarker assessment 2. Estimate prevalence of the following markers from the oral rinse, saliva sample, and blood (whole blood, plasma, and serum), and tumor block: a. HPV DNA genotype and RNA expression among HPV positive b. Immunological factors (tumor, oral and circulating immune markers) c. HPV viral and host epigenetic factors (e.g., HPV L1 methylation) d. p16 expression (marker of HPV-mediated cell cycle deregulation) 3. Among newly recruited OPC cases, assess biomarker changes through the course of treatment and the relationship to treatment outcomes. 4. Among early and late disease pre-treatment OPC cases and controls matched by sex, age, race/ethnicity, and tobacco (nested case control) to cases: a. Estimate the sensitivity and specificity of a combined HPV 16 DNA and host gene methylation oral biomarker panel, in this interval validation study using pre-specified cutpoints from work already completed by us. b. Assess oral biomarker panel test characteristics (AUC) alone and with the addition of potential risk stratifiers (e.g., sex, age, oral health) to detect OPC early c. Assess within lab and inter lab reliability of biomarker panel

  • Inclusion Criteria

      Inclusion Criteria:
    • Men, ages 18 years and older
    • Diagnosed with Stages I-IV oropharynx cancer of the base of tongue, tonsils, or soft pallet.
    • Post 4 week of radiation or chemotherapy if treated for different disease
    • Fully understands study procedures, risks involved in the study, and voluntarily agrees to participate by giving written informed consent Criteria for controls:
    • Age 35 years and older (median age for OPC diagnosis is 52)
    • No history of cancer (excluding non-melanoma skin cancer)
    • Fully understands study procedures, risks involved in the study, and voluntarily agrees to participate by providing informed consent.
  • Exclusion Criteria

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