Oropharynx (OPX) Biomarker Trial
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.
• 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 points for a total of 3 time-points including pre-treatment. A participant who does not return in person to Mayo Clinic Rochester for every standard of care post-treatment follow up will not be considered deviating from the protocol
• Group 4:
‣ Clinical suspicion or histopathologic diagnosis of head and neck cancer or neoplasm
• Primary salivary neoplasm
∙ Primary thyroid neoplasm
∙ Primary head and neck neoplasm
∙ Multi-cancer early detection (MCED) testing concerning for cancer
• Patient has given permission to give his/her tumor/tissue/blood/saliva sample for research testing
• Ability to complete questionnaire(s) by themselves or with assistance
• Primary language: English, Spanish, Arabic