Mayo Clinic
The purpose of this research is to identify a biomarker that is exists when human papillomavirus (HPV) mediated oropharyngeal squamous cell carcinoma is present and does not exist when HPV mediated oropharyngeal squamous cell carcinoma is absent.
PRIMARY OBJECTIVE: I. To identify a biomarker (or biomarkers) that is present when disease is present (i.e., at diagnosis or recurrence) and not present when disease is absent (i.e., after treatment, in HPV negative patients or in normal controls). OUTLINE: This is an observational study. Patients undergo blood sample collection, saliva sample collection, complete questionnaires and have their medical records reviewed on study.
Inclusion Criteria: * Age ≥ 18 years * Able to provide written consent * Groups 1-3: * Must undergo p16 staining on biopsy for enrollment * Patients with \< 70% of tumor cells positive for p16 will be considered p16 negative * Must undergo HPV16 family in situ hybridization (ISH) and/or RNA on biopsy or surgical specimen, unless amount of tissue is too small to have conclusive HPV ISH testing done on it * Willingness and intent to return in person to enrolling institution for follow-up (during the Active Monitoring Phase of the study) for at least 2 of the standard follow-up time poi…
Non-interventional study
Arctuva estimate
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