Clinical Trials

Inclusion Criteria:

• Age ≥ 18 years.
• Able to provide written consent.
• All patients must undergo p16 staining on biopsy for enrollment.
• All patients must undergo HPV16 family 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.
• Patients with < 70% of tumor cells positive for p16 will be considered p16 negative
• Patient has given permission to give his/her tumor/tissue/blood/saliva sample for research testing.
• Clinical diagnosis of oropharyngeal squamous cell carcinoma or clinical diagnosis of HPV negative oral cavity cancer, to be enrolled for subgroup 1D.
• Ability to complete questionnaire(s) by themselves or with assistance.
• 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. 

Exclusion Criteria:

• Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm. Patients enrolled in DART are eligible.
• 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.
  • Note:  If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer.

Eligibility last updated 6/3/22. Questions regarding updates should be directed to the study team contact.