Oropharynx (OPX) Biomarker Trial
Recruiting now
Conditions studied: 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 Carcinoma, Oropharyngeal Squamous Cell Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma, Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Head and Neck Carcinoma, Head and Neck Neoplasm, Salivary Gland Neoplasms, Thyroid Gland Neoplasm
In brief
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.
Key facts
- Study ID
- NCT06356272
- Run by
- Mayo Clinic
- People needed
- 560
- Starts
- 2019-11-15
- Expected to finish
- 2029-11-30
- Last updated by the study team
- 2026-04-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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:
- 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
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
- 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
Where it is running
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.