Oropharynx (OPX) Biomarker Trial

April 17, 2026 updated by: Mayo Clinic
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. 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.

Study Type

Observational

Enrollment (Estimated)

560

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kathryn M. Van Abel, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults > 18 years of age with newly diagnosed untreated, progressive, or metastatic oropharyngeal squamous cell carcinoma with known HPV status

Description

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

  • 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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational
Patients undergo blood sample collection, saliva sample collection, complete questionnaires and have their medical records reviewed on study.
Other: Non-Interventional Study
Non-interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in biomarkers
Time Frame: Up 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).
Up to 24 months
Oncologic outcomes associated with biomarkers
Time Frame: Up 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.
Up to study completionUp to 24 months
Genetic alterations
Time Frame: Up 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
Up to 24 months
Immunologic biomarkers for diagnosis
Time Frame: Up to 24 months
Detected immunologic biomarkers will be compared with overall survival to determine whether biomarkers can be used to predict diagnosis.
Up to 24 months
Immunologic biomarkers for prognosis
Time Frame: Up to 24 months
Detected immunologic biomarkers will be compared with overall survival to determine whether biomarkers can be used to predict prognosis.
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Kathryn M. Van Abel, MD, Mayo Clinic in Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2019

Primary Completion (Estimated)

November 30, 2029

Study Completion (Estimated)

November 30, 2029

Study Registration Dates

First Submitted

April 4, 2024

First Submitted That Met QC Criteria

April 4, 2024

First Posted (Actual)

April 10, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-006036 (Other Identifier: Mayo Clinic Institutional Review Board)
  • NCI-2024-00965 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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