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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUNC Lineberger Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

≥ 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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

220 Participants
are grouped into 1 trial group

Sponsors and collaborators

UNC Lineberger Comprehensive Cancer Center

Lead sponsor

Mayo Clinic

Collaborator

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator