Actively Recruiting
Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC
Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2026-04-28
220
Participants Needed
3
Research Sites
675 weeks
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
The primary goal of this study is to examine whether recurrence of HPV-associated OPSCC can be predicted by two factors: 1) mutations in genes called TRAF3 and CYLD, and 2) measurements of circulating HPV DNA in blood plasma. The study will also investigate whether HPV integration is associated with TRAF3 and CYLD mutations, and whether recurrence prediction improves when looking at HPV integration along with TRAF3 and CYLD mutations.
CONDITIONS
Official 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
- T0-T2 N2a-N3 M0 or T3-T4 N0-N3 M0 (AJCC 7th edition)
- Biopsy proven squamous cell carcinoma of the oropharynx or unknown primary
- No prior therapy
- No evidence of distant metastatic disease
- p16 positive = diffuse ≥ 70% tumor cell expression, with at least moderate (2/3+) staining intensity
- Planned for receipt of definitive cancer treatment
- ECOG Performance Status 0-1
- Patients must be deemed able to comply with the treatment plan and follow-up schedule.
- Patients must provide study specific informed consent prior to study entry
You will not qualify if you...
All subjects meeting any of the exclusion criteria at baseline will be excluded from study participation:
- Prior history of radiation therapy to the 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
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
CONTACT
W
Wendell Yarbrough, MD
CONTACT
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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