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RecruitingClinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Metastatic Oropharyngeal Squamous Cell Carcinoma

Oropharynx (OPX) Biomarker Trial

Eligible age

18+ yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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About this study

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.

Sponsor: Mayo Clinic

You may qualify if…

  • ✓ 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:

You may not qualify if…

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

Where it's recruiting

Minnesota

Rochester

Source: ClinicalTrials.gov · NCT06356272 · last updated 2026-04-22

Oropharynx (OPX) Biomarker Trial · TrialPath