Recruiting

Observational Study

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT04564989

Conditions

Oropharyngeal Squamous Cell Carcinoma

Carcinoma, Squamous Cell

Head and Neck Squamous Cell Carcinoma

Oropharynx Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Oropharyngeal Squamous Cell Carcinoma

Carcinoma, Squamous Cell

Head and Neck Squamous Cell Carcinoma

Oropharynx Squamous Cell Carcinoma

Study ID

NCT04564989

Start date

Nov 19, 2020

Status verified date

Apr, 2026

Completion date

Nov, 2033

Anticipated

Primary completion date

Nov, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

220 participants

Anticipated

Interventions and Outcome Measures

Arms

HPV+ OPSCC Patients

Patients with p16+ squamous cell carcinoma of the oropharynx (or unknown primary) who will receive definitive cancer treatment.

Primary outcome measure

  • Recurrence of OPSCC [ Time Frame: From date of therapy completion until biopsy-proven recurrence, assessed up to 5 years ]
  • Progression-free survival [ Time Frame: From beginning or end of treatment until date of CT-detected recurrence or date of death, assessed up to 5 years ]
  • Positive Predictive Value [ Time Frame: Baseline to up to 5 years ]
  • Negative Predictive Value [ Time Frame: Baseline to up to 5 years ]
  • Quality of Life questionnaire [ Time Frame: Baseline until recurrence or up to 5 years ]

Central Contacts and Locations

Central contacts

Lori Stravers

919-966-4432lori_stravers@med.unc.edu

Wendell Yarbrough, MD

919-843-7091dell@med.unc.edu

Locations

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Tuvara King

919-966-4432tjking@med.unc.edu

Principal Investigator:

Wendell Yarbrough, MD

Trident Medical Center (HCA Healthcare )

Recruiting

North Charleston, South Carolina, United States, 29406

Contacts

Vera Markovic

843-998-2819Vera.Markovic@hcahealthcare.com

David Neskey, MD

843-998-2819david.neskey@sarahcannon.com

Principal Investigator:

David Neskey, MD

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Apr 28, 2026

Last verified

Apr, 2026

Keywords

  • Human Papillomavirus
  • HPV
  • p16
  • Oropharynx
  • OPSCC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-04-28.