Oropharynx (OPX) Biomarker Trial

NCT06356272 | Recruiting

• 2 other identifiers: 19-006036NCI-2024-00965
• Study Type: observational
• Target: 560
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Oropharyngeal Squamous Cell Carcinoma; Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; 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

Outcome Measures

Primary Outcomes (5)

• Change in biomarkers

  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).

  Up to 24 months

• Oncologic outcomes associated with biomarkers

  Survival outcome (overall survival, disease-free survival, and distant failure) will be compared with blood, tissue and saliva biomarkers identified throughout the treatment course.

  Up to study completionUp to 24 months

• Genetic alterations

  Alterations in oropharynx tumor specimens will be compared with the detection rate of corresponding circulating DNA in oropharynx cancer patients throughout their treatment course

  Up to 24 months

• Immunologic biomarkers for diagnosis

  Detected immunologic biomarkers will be compared with overall survival to determine whether biomarkers can be used to predict diagnosis.

  Up to 24 months

• Immunologic biomarkers for prognosis

  Detected immunologic biomarkers will be compared with overall survival to determine whether biomarkers can be used to predict prognosis.

  Up to 24 months

Study Arms (1)

Observational

Patients undergo blood sample collection, saliva sample collection, complete questionnaires and have their medical records reviewed on study.

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-interventional study

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Participants indicate whether their biospecimen samples (tissue from surgical sample, blood samples, and/or saliva samples) can be retained after the study for future research use.

MeSH Terms

Conditions

Oropharyngeal Neoplasms; Squamous Cell Carcinoma of Head and Neck; Carcinoma; Head and Neck Neoplasms; Salivary Gland Neoplasms; Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Carcinoma, Squamous Cell; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Mouth Neoplasms; Mouth Diseases; Salivary Gland Diseases; Endocrine Gland Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Kathryn M. Van Abel, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 10, 2024
• Study Start: November 15, 2019
• Primary Completion (Estimated): November 30, 2029
• Study Completion (Estimated): November 30, 2029
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

US (1)