Actively Recruiting
Oropharynx (OPX) Biomarker Trial
Led by Mayo Clinic ยท Updated on 2026-04-22
560
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying oropharyngeal squamous cell carcinoma caused by human papillomavirus (HPV) to find biomarkers that indicate when the disease is present or absent. This observational study aims to identify markers found at diagnosis or recurrence but not after treatment, in HPV-negative patients, or in healthy controls. The goal is to improve diagnosis and understanding of this cancer type. Participants will provide blood and saliva samples, complete questionnaires, and allow review of their medical records. The study does not involve treatment but observes patients over time to collect data. There is an active monitoring phase requiring at least two follow-up visits in person, including one pre-treatment visit, to track biomarker changes and disease status. During the study, researchers will measure changes in biomarkers, genetic alterations, and immunologic markers related to diagnosis and prognosis up to 24 months. Participants will be involved in sample collections and questionnaires. The study monitors oncologic outcomes associated with biomarkers and collects data through medical record reviews. Participation lasts up to two years, with ongoing evaluation of health and biomarker status.
CONDITIONS
Brief Title
Oropharynx (OPX) Biomarker Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Able to provide written consent
- Must undergo p16 staining on biopsy for enrollment
- Patients with less than 70% of tumor cells positive for p16 are considered p16 negative
- Must undergo HPV16 family in situ hybridization and/or RNA testing on biopsy or surgical specimen unless tissue is insufficient
- Willingness and intent to return in person for at least two standard follow-up visits including pre-treatment
- Clinical suspicion or histopathologic diagnosis of head and neck cancer or neoplasm (including primary salivary, thyroid, head and neck neoplasms, or multi-cancer early detection testing concerning for cancer)
- Permission to provide tumor/tissue/blood/saliva samples for research
- Ability to complete questionnaires independently or with assistance
- Primary language: English, Spanish, or Arabic
You will not qualify if you...
- Receiving any other investigational agent considered as treatment for the primary neoplasm
- Other active malignancy within 5 years prior to registration (except non-melanotic skin cancer, non-metastatic thyroid or prostate cancer, carcinoma-in-situ of the cervix, or HPV+ oropharyngeal squamous cell carcinoma in group 3)
- History of any head and neck malignancy other than the current tumor
- For group 4 cohorts A, B, C: other active malignancy within 5 years prior to registration with exceptions for non-metastatic prostate cancer, carcinoma-in-situ of the cervix, and non-metastatic basal cell carcinoma
- History of any head and neck malignancy other than the present neoplasm
- Groups 4 cohorts D and E allow other active malignancy or recurrent head and neck neoplasms and receipt of cancer-specific therapy for other malignancies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 24 months
Participants undergo blood and saliva sample collection, complete questionnaires, and have their medical records reviewed throughout the study.
At least two standard follow-up visits including pre-treatment visits
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
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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