Recruiting

Biomarker Trial

Sponsor:

Mayo Clinic

Code:

NCT06356272

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-Interventional Study

Study Details

Brief 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.

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

Study ID

NCT06356272

Start date

Nov 15, 2019

Status verified date

Apr, 2026

Completion date

Nov 30, 2029

Anticipated

Primary completion date

Nov 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

560 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational

Patients undergo blood sample collection, saliva sample collection, complete questionnaires and have their medical records reviewed on study.

Interventions

Non-Interventional Study

Non-interventional study

Primary outcome measure

  • Change in biomarkers [ Time Frame: Up to 24 months ]
  • Oncologic outcomes associated with biomarkers [ Time Frame: Up to study completionUp to 24 months ]
  • Genetic alterations [ Time Frame: Up to 24 months ]
  • Immunologic biomarkers for diagnosis [ Time Frame: Up to 24 months ]
  • Immunologic biomarkers for prognosis [ Time Frame: Up to 24 months ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Diane Vogen

507-266-1247Vogen.Diane2@mayo.edu

Principal Investigator:

Kathryn M. Van Abel, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-04-22.