Clinical trial NCT06356272: Oropharynx (OPX) Biomarker Trial
Official title: Oropharynx (OPX) Biomarker Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC V8
Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC V8
Head and Neck Carcinoma
Head and Neck Neoplasm
Salivary Gland Neoplasms
Thyroid Gland Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults \> 18 years of age with newly diagnosed untreated, progressive, or metastatic oropharyngeal squamous cell carcinoma with known HPV status

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.

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.

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

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

Primary outcomes:
measure: Change in biomarkers
timeFrame: Up to 24 months
measure: Oncologic outcomes associated with biomarkers
timeFrame: Up to study completionUp to 24 months
measure: Genetic alterations
timeFrame: Up to 24 months
measure: Immunologic biomarkers for diagnosis
timeFrame: Up to 24 months
measure: Immunologic biomarkers for prognosis
timeFrame: Up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Kathryn M. Van Abel, MD
role: PRINCIPAL_INVESTIGATOR
References: