Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8NCT06356272
Oropharynx (OPX) Biomarker Trial
An observational study of Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 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
- What is being tested?
- Non-Interventional Study
- How many people
- 560 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2019to 30 Nov 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults > 18 years of age with newly diagnosed untreated, progressive, or metastatic oropharyngeal squamous cell carcinoma with known HPV status
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Diane Vogen, 507-266-1247, Vogen.Diane2@mayo.edu
About this study
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To identify 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).
OUTLINE: This is an observational study.
Patients undergo blood sample collection, saliva sample collection, complete questionnaires and have their medical records reviewed on study.
- 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
- Being tested
- Non-Interventional Study
- Medical subject headings
- Oropharyngeal Neoplasms, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Head and Neck Neoplasms, Salivary Gland Neoplasms, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Patients undergo blood sample collection, saliva sample collection, complete questionnaires and have their medical records reviewed on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in biomarkers
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).
Measured: Up to 24 months
Oncologic outcomes associated with biomarkers
Survival outcome (overall survival, disease-free survival, and distant failure) will be compared with blood, tissue and saliva biomarkers identified throughout the treatment course.
Measured: Up to study completionUp to 24 months
Genetic alterations
Alterations in oropharynx tumor specimens will be compared with the detection rate of corresponding circulating DNA in oropharynx cancer patients throughout their treatment course
Measured: Up to 24 months
Immunologic biomarkers for diagnosis
Detected immunologic biomarkers will be compared with overall survival to determine whether biomarkers can be used to predict diagnosis.
Measured: Up to 24 months
Immunologic biomarkers for prognosis
Detected immunologic biomarkers will be compared with overall survival to determine whether biomarkers can be used to predict prognosis.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start15 Nov 2019
- Primary completion30 Nov 2029 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathryn M. Van Abel, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06356272
- Sponsor's protocol ID
- 19-006036
- Other IDs
- NCI-2024-00965, 19-006036
- Status last verified
- Apr 2026
- First submitted
- 4 Apr 2024
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No