Oropharynx (OPX) Biomarker Trial

Prior treatment

• Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.

Age

• Groups 1-3:
  • Other active malignancy ≤ 5 years prior to registration
  • EXCEPTIONS: Non-melanotic skin cancer, non-metastatic thyroid cancer, non-metastatic prostate cancer, carcinoma-in-situ of the cervix, HPV+ oropharyngeal squamous cell carcinoma (SCC) (which can be enrolled in group 3)
  • NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer
  • History of any head and neck malignancy, other than the tumor for which they are being treated
• Group 4, Cohort A, B, C:
  • Other active malignancy ≤ 5 years prior to registration
  • EXCEPTIONS: Non-metastatic prostate cancer, carcinoma-in-situ of the cervix, non metastatic cutaneous basal cell carcinoma
  • NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer
  • History of any head and neck malignancy, other than the present neoplasm
  • Note these are clarifications of inclusion into Group 4, Cohorts D and E:
  • Presence of other active malignancy or recurrent head and neck neoplasms are allowed in this arm
  • Receipt of cancer specific therapy for other malignancy is allowed in this arm

• 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