Oropharynx (OPX) Biomarker Trial

Description

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.

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

Study Overview

Study Details

Study 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.

Oropharynx (OPX) Biomarker Trial

Oropharynx (OPX) Biomarker Trial

Condition
Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC V8
Intervention / Treatment

-

Contacts and Locations

Rochester

Mayo Clinic in Rochester, Rochester, Minnesota, United States, 55905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mayo Clinic,

Kathryn M. Van Abel, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

2029-11-30