Oropharynx (OPX) Biomarker Trial

Mayo Clinic

Status: Enrolling

Conditions: Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Metastatic Oropharyngeal Squamous Cell Carcinoma; Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8; Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8; Recurrent Oropharyngeal Squamous Cell Carcinoma; Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Oropharyngeal Squamous Cell Carcinoma

Treatments: Other: Non-Interventional Study

Study type: Observational

Funder types: Other

Identifiers

NCT06356272

19-006036 (Other Identifier)

NCI-2024-00965 (Registry Identifier)

Details and patient eligibility

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• * Age ≥ 18 years

  • Able to provide written consent
  • All patients must undergo p16 staining on biopsy for enrollment
  • All patients must undergo HPV16 family 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
  • Patients with < 70% of tumor cells positive for p16 will be considered p16 negative
  • Patient has given permission to give his/her tumor/tissue/blood/saliva sample for research testing
  • Clinical diagnosis of oropharyngeal squamous cell carcinoma or clinical diagnosis of HPV negative oral cavity cancer, to be enrolled for subgroup 1D
  • Ability to complete questionnaire(s) by themselves or with assistance
  • 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

Exclusion criteria

• * Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm. Patients enrolled in DART are eligible

  • History of any head and neck malignancy, other than HPV+ oropharyngeal squamous cell carcinoma

  • 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 SCC (which can be enrolled in group 3)
    • NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer

Trial design

180 participants in 1 patient group

Observational

Description:

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

Treatment:

Other: Non-Interventional Study