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Observational Study for HPV-Mediated Oropharyngeal Carcinoma Biomarkers

This observational study aims to find a "biomarker" (a measurable indicator) that is present when human papillomavirus (HPV)-mediated oropharyngeal squamous cell carcinoma (a type of throat cancer linked to HPV) is active, and absent when it's not. This could help doctors better understand and manage the disease. You might be eligible if you are 18 or older and have HPV-mediated oropharyngeal carcinoma, which will be confirmed by specific tests (p16 staining and HPV testing) on your biopsy. The study is looking to enroll 560 participants. Success would mean identifying a reliable biomarker that changes with the presence or absence of the disease, which could lead to improved diagnosis or monitoring.

Study design
This is an observational study, meaning no new treatments are given. It plans to enroll 560 participants.
What's involved
You would provide blood and saliva samples, complete questionnaires, and have your medical records reviewed.
Compensation
Not stated in the trial record.
Follow-up
Your biomarkers and oncologic outcomes will be measured for up to 24 months.

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NCT06356272

Oropharynx (OPX) Biomarker Trial

Recruiting
Not specifiedAges 18+Observational
Mayo Clinic
~560 participants
Updated 2026-04-22 on ClinicalTrials.gov
What's tested:Non-Interventional Study

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in biomarkers
Measured over Up to 24 months
+4 more outcomes measured

Conditions

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

Explore related trials

Head and Neck CarcinomaOropharyngeal Squamous Cell CarcinomaSalivary Gland NeoplasmThyroid Gland NeoplasmCDKN2A wt AlleleHPV

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Kathryn M. Van Abel, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Change in biomarkersUp to 24 months

    Biospecimen samples will be assessed for a biomarker (or biomarkers) that is present when disease is present (i.e., at diagnosis or recurrence) and not present when disease is absent (i.e., after treatment, in HPV negative patients or in normal controls).

  • Oncologic outcomes associated with biomarkersUp to study completionUp to 24 months

    Survival outcome (overall survival, disease-free survival, and distant failure) will be compared with blood, tissue and saliva biomarkers identified throughout the treatment course.

  • Genetic alterationsUp to 24 months

    Alterations in oropharynx tumor specimens will be compared with the detection rate of corresponding circulating DNA in oropharynx cancer patients throughout their treatment course

  • Immunologic biomarkers for diagnosisUp to 24 months

    Detected immunologic biomarkers will be compared with overall survival to determine whether biomarkers can be used to predict diagnosis.

  • Immunologic biomarkers for prognosisUp to 24 months

    Detected immunologic biomarkers will be compared with overall survival to determine whether biomarkers can be used to predict prognosis.