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Observational Study for HPV-associated Oropharyngeal Squamous Cell Carcinoma

This observational study aims to understand if certain factors can predict whether HPV-associated oropharyngeal squamous cell carcinoma (OPSCC), a type of head and neck cancer, will return. Researchers are looking at changes in genes called TRAF3 and CYLD, and levels of HPV DNA in blood. They will also explore if HPV integration (when the virus's DNA becomes part of your cells' DNA) is linked to these gene changes and if it helps predict recurrence. You may be eligible if you are 18 or older, have newly diagnosed OPSCC that is p16 positive, and have not had prior treatment. The study will track recurrence and how long you live without the cancer progressing for up to 5 years.

Study design
This is an observational study, meaning researchers will watch and collect information without providing specific treatments. It plans to enroll 220 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for recurrence and progression-free survival for up to 5 years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04564989

Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC

Recruiting
Not specifiedAges 18+Observational
UNC Lineberger Comprehensive Cancer Center
~220 participants
Updated 2026-04-28 on ClinicalTrials.gov

At a glance

Recruiting sites
2 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recurrence of OPSCC
Measured over From date of therapy completion until biopsy-proven recurrence, assessed up to 5 years
+4 more outcomes measured

Conditions

Oropharyngeal Squamous Cell Carcinoma
Carcinoma, Squamous Cell
Head and Neck Squamous Cell Carcinoma
Oropharynx Squamous Cell Carcinoma

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Where it's being run

3 sites across 3 states
Minnesota1
North Carolina1
South Carolina1

Study leadership

  • Wendell Yarbrough, MD · PRINCIPAL_INVESTIGATOR · UNC Chapel Hill

Who to contact

Lori Stravers
[email protected]
919-966-4432
Email the study team

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Eligibility criteria

Inclusion

≥ 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

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

What this trial measures

  • Recurrence of OPSCCFrom date of therapy completion until biopsy-proven recurrence, assessed up to 5 years

    Patients will undergo post-treatment CT scans per institutional standard of care to detect cancer recurrence. Status of recurrence of OPSCC will be confirmed based on biopsy.

  • Progression-free survivalFrom beginning or end of treatment until date of CT-detected recurrence or date of death, assessed up to 5 years

    Time-to-recurrence will be defined as time lapsed from end (or start) of treatment to first date recurrence (biopsy proven occur later) is detected by CT scans, or death. Otherwise, time-to-recurrence is censored at end of study date.

  • Positive Predictive ValueBaseline to up to 5 years

    Positive Predictive Value (PPV) is defined as probability that patients with two consecutive positive cHPVDNA (i.e., detectable cHPVDNA) really develop OPSCC recurrence during the study period.

  • Negative Predictive ValueBaseline to up to 5 years

    Negative Predictive Value (NPV) is defined as probability that patients without two consecutive positive cHPVDNA do not develop OPSCC recurrence during the study period.

  • Quality of Life questionnaireBaseline until recurrence or up to 5 years

    At specified timepoints before, during, and after treatment, patients will complete a questionnaire comprised of questions from the European Organization for Research and Treatment of Cancer (EORTC) QLQ H\&N35, which is for head and neck cancer patients, and EORTC QLQ C30, which is a general cancer assessment.