Oropharynx (OPX) Biomarker Trial

Oropharyngeal Squamous Cell Carcinoma Clinical Trial

Official title:

Oropharynx (OPX) Biomarker Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06356272
• Other study ID #: 19-006036
• Secondary ID: NCI-2024-0096519
• Status: Recruiting
• Start date: November 15, 2019
• Est. completion date: December 15, 2025

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 15, 2025
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• * Age = 18 years

• Able to provide written consent

• All patients must undergo p16 staining on biopsy for enrollment

• All patients must undergo HPV16 family 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

• Patients with < 70% of tumor cells positive for p16 will be considered p16 negative

• Patient has given permission to give his/her tumor/tissue/blood/saliva sample for research testing

• Clinical diagnosis of oropharyngeal squamous cell carcinoma or clinical diagnosis of HPV negative oral cavity cancer, to be enrolled for subgroup 1D

• Ability to complete questionnaire(s) by themselves or with assistance

• 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

Exclusion Criteria:

• * Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm. Patients enrolled in DART are eligible

• History of any head and neck malignancy, other than HPV+ oropharyngeal squamous cell carcinoma

• 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 SCC (which can be enrolled in group 3)

• NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
• Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
• Oropharyngeal Neoplasms
• Oropharyngeal Squamous Cell Carcinoma
• Recurrent Oropharyngeal Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck
• Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8
• Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8

Intervention

Other:
• Non-Interventional Study
Non-interventional study

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Immunologic biomarkers for predicting progression free survival	Detected immunologic biomarkers will be compared with overall survival to determine whether biomarkers can be used to predict likelihood of progression free survival.	Up to 24 months