NCT04564989 · UNC Lineberger Comprehensive Cancer Center
Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC
What this study 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.
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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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- ≥ 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
Exclusion criteria
- 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
Where
- Rochester, Minnesota
- Chapel Hill, North Carolina
- North Charleston, South Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 28, 2026 · Source of record for eligibility and locations