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.
| Condition(s) | Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Metastatic Oropharyngeal Squamous Cell Ca |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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. |
| Who can participate | 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 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 deviatin |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Mayo Clinic |
| Locations | Rochester, Minnesota, United States |
| Start date | 2019-11-15 |
| NCT ID | NCT06356272 |
| Official listing | https://clinicaltrials.gov/study/NCT06356272 |