Oropharynx (OPX) Biomarker Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-Interventional Study.
- Who it may be relevant to
- Registry 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. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
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.
Interventions
- Other Non-Interventional Study
Non-interventional study
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT06356272 · 19-006036 · NCI-2024-00965 · 19-006036