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RecruitingNCT06356272

Oropharynx (OPX) Biomarker Trial

Sponsor

Mayo Clinic

Enrollment

440 participants

Start Date

Nov 15, 2019

Study Type

OBSERVATIONAL

Conditions

Head and Neck CarcinomaClinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Metastatic Oropharyngeal Squamous Cell CarcinomaStage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8Oropharyngeal Squamous Cell CarcinomaRecurrent Oropharyngeal Squamous Cell CarcinomaHead and Neck NeoplasmSalivary Gland NeoplasmsThyroid Gland Neoplasm

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria15

  • 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 Criteria14

  • 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

Interventions

OTHERNon-Interventional Study

Non-interventional study

Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT06356272

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