Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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 population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Non-Interventional Study

    Other intervention

    Non-interventional study

Treatment groups

560 Participants
are divided into 1 treatment group
Group A: Observational1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Up to 24 months
2

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.

Time frame
Up to study completionUp to 24 months
3

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

Time frame
Up to 24 months
4

Immunologic biomarkers for diagnosis

Detected immunologic biomarkers will be compared with overall survival to determine whether biomarkers can be used to predict diagnosis.

Time frame
Up to 24 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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