Actively Recruiting
Oropharynx (OPX) Biomarker Trial
Led by Mayo Clinic · Updated on 2026-04-22
560
Participants Needed
1
Research Sites
524 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Oropharynx (OPX) Biomarker Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 18 years
- Able to provide written consent
- Patients in Groups 1-3 must undergo p16 staining on biopsy for enrollment
- Patients with less than 70% of tumor cells positive for p16 are considered p16 negative
- Patients in Groups 1-3 must undergo HPV16 family in situ hybridization (ISH) and/or RNA testing on biopsy or surgical specimen unless tissue is too small
- Willingness and intent to return in person to the enrolling institution for at least 2 standard follow-up time points including pre-treatment
- Patients in Group 4 must have clinical suspicion or histopathologic diagnosis of primary salivary, thyroid, head and neck neoplasm, or multi-cancer early detection testing concerning for cancer
- Permission given to use tumor, tissue, blood, or saliva samples for research
- Ability to complete questionnaires independently or with assistance
- Primary language is English, Spanish, or Arabic
You will not qualify if you...
- Receiving any other investigational agent considered treatment for the primary neoplasm
- For Groups 1-3: other active malignancy within 5 years prior to registration except non-melanotic skin cancer, non-metastatic thyroid cancer, non-metastatic prostate cancer, carcinoma-in-situ of the cervix, or HPV+ oropharyngeal squamous cell carcinoma in group 3
- For Groups 1-3: history of any head and neck malignancy other than the tumor being treated
- For Group 4, Cohorts A, B, C: other active malignancy within 5 years prior to registration except non-metastatic prostate cancer, carcinoma-in-situ of the cervix, or non-metastatic cutaneous basal cell carcinoma
- For Group 4, Cohorts A, B, C: history of any head and neck malignancy other than the present neoplasm
- Presence of other active malignancy or recurrent head and neck neoplasms allowed only in Group 4, Cohorts D and E
- Receipt of cancer-specific therapy for other malignancy allowed only in Group 4, Cohorts D and E
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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