Oropharynx (OPX) Biomarker Trial

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
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06356272
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2019-11-15
• Study First Submitted: 2024-04-04
• Study First Submitted QC: 2024-04-04
• Study First Posted: 2024-04-10
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02
• Primary Completion: 2029-11-30
• Study Completion: 2029-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Non-Interventional Study	Patients undergo blood sample collection, saliva sample collection, complete questionnaires and have their medical records reviewed on study.

Primary Outcome Measures

Name	Time	Method
Genetic alterations	Up to 24 months	Alterations in oropharynx tumor specimens will be compared with the detection rate of corresponding circulating DNA in oropharynx cancer patients throughout their treatment course
Immunologic biomarkers for diagnosis	Up to 24 months	Detected immunologic biomarkers will be compared with overall survival to determine whether biomarkers can be used to predict diagnosis.
Immunologic biomarkers for prognosis	Up to 24 months	Detected immunologic biomarkers will be compared with overall survival to determine whether biomarkers can be used to predict prognosis.
Change in biomarkers	Up to 24 months	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).
Oncologic outcomes associated with biomarkers	Up to study completionUp to 24 months	Survival outcome (overall survival, disease-free survival, and distant failure) will be compared with blood, tissue and saliva biomarkers identified throughout the treatment course.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States