Identifying biomarkers for HPV-related oropharyngeal cancer
Oropharynx (OPX) Biomarker Trial
This study is trying to find specific markers in blood and saliva that can help identify HPV-related throat cancer in patients who are already diagnosed with advanced stages of the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 560 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06356272 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify specific biomarkers that indicate the presence of HPV-mediated oropharyngeal squamous cell carcinoma. Participants will provide blood and saliva samples, complete questionnaires, and have their medical records reviewed. The study focuses on patients diagnosed with clinical stage III or IV HPV-positive oropharyngeal carcinoma, as well as those with recurrent or metastatic forms of the disease. The goal is to find biomarkers that are present during disease states and absent in healthy individuals or those without the disease.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of HPV-mediated oropharyngeal carcinoma who are willing to participate in follow-up visits.
Not a fit: Patients with HPV-negative oropharyngeal carcinoma or those who do not meet the eligibility criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic tools for early detection and monitoring of HPV-related oropharyngeal cancer.
How similar studies have performed: Other studies have explored biomarkers in HPV-related cancers, but this specific approach to identifying biomarkers in oropharyngeal carcinoma is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
* Primary language: English, Spanish, Arabic
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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Kathryn M. Van Abel, MD — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.