NCT06356272 · Mayo Clinic
Oropharynx (OPX) Biomarker Trial
What this study 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.
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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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 deviating from the protocol
- 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
Exclusion criteria
- 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
- Rochester, Minnesota
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 22, 2026 · Source of record for eligibility and locations