LCCC 2044: Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC

  • End date
    Nov 19, 2025
  • participants needed
  • sponsor
    UNC Lineberger Comprehensive Cancer Center
Updated on 19 October 2022


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.

Condition Oropharyngeal Squamous Cell Carcinoma, Carcinoma, Squamous Cell, Head and Neck Squamous Cell Carcinoma, Oropharynx Squamous Cell Carcinoma
Clinical Study IdentifierNCT04564989
SponsorUNC Lineberger Comprehensive Cancer Center
Last Modified on19 October 2022


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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