Actively Recruiting
Prospective Observational Study to Validate Circulating HPV DNA and Prognostic Genomic Biomarkers in HPV-associated Oropharyngeal Squamous Cell Carcinoma
Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2026-04-28
220
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
U
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor
M
Mayo Clinic
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether the recurrence of HPV-associated oropharyngeal squamous cell carcinoma (OPSCC) can be predicted by specific genetic mutations and blood markers. The study focuses on mutations in the TRAF3 and CYLD genes and measurements of circulating HPV DNA in blood plasma. It also examines the relationship between HPV integration and these mutations to improve prediction of cancer recurrence. This observational study involves patients with p16 positive squamous cell carcinoma of the oropharynx or unknown primary who are planned to receive definitive cancer treatment. Participants are monitored without assigned treatments, as this study observes their condition and collects data over time. Participants will be followed for up to 5 years after their cancer therapy completion. During this time, researchers will assess recurrence through biopsy confirmation and imaging, monitor progression-free survival, and evaluate the predictive values of the biomarkers. Quality of life questionnaires will also be completed periodically until recurrence or the end of follow-up. The study aims to better understand how these biomarkers relate to disease outcomes.
CONDITIONS
Brief Title
Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- T0-T2 N2a-N3 M0 or T3-T4 N0-N3 M0 stage according to AJCC 7th edition
- Biopsy confirmed squamous cell carcinoma of the oropharynx or unknown primary
- No prior therapy for this cancer
- No evidence of distant metastatic disease
- p16 positive tumor with diffuse expression of at least 70% tumor cells and moderate or higher staining intensity
- Planned to receive definitive cancer treatment
- ECOG Performance Status of 0 or 1
- Able to comply with treatment plan and follow-up schedule
- Provide informed consent specific to this study
You will not qualify if you...
- Prior radiation therapy to head and neck
- Prior history of head and neck cancer
- Inadequate pre-treatment tissue sample for tumor genomic analyses
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 5 years
Participants who receive definitive cancer treatment are observed to validate circulating HPV DNA and prognostic genomic biomarkers in HPV-associated oropharyngeal squamous cell carcinoma.
Trial Site Locations
Total: 3 locations
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Active, Not Recruiting
2
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
3
Trident Medical Center (HCA Healthcare )
North Charleston, South Carolina, United States, 29406
Actively Recruiting
Research Team
L
Lori Stravers
W
Wendell Yarbrough, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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