Health Trials

Oropharynx (OPX) Biomarker Trial

ConditionsClinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Metastatic Oropharyngeal Squamous Cell CarcinomaOropharyngeal Squamous Cell CarcinomaRecurrent Oropharyngeal Squamous Cell CarcinomaStage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8Head and Neck CarcinomaHead and Neck NeoplasmSalivary Gland NeoplasmsThyroid Gland Neoplasm
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥ 18 years

Able to provide written consent

Must undergo p16 staining on biopsy for enrollment

Patients with < 70% of tumor cells positive for p16 will be considered p16 negative

Disqualifiers

Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.

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

Trial design

Treatments tested in this trial

  • Non-Interventional Study

Treatment groups

560 Participants
are divided into 1 treatment group

Sponsors and collaborators

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov