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.
≥ 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
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
Patients with HPV+ oropharyngeal squamous cell carcinoma who will receive definitive cancer treatment.
Cohort
Prospective
Not listed
Recurrence of OPSCC
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 survival
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 Value
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 Value
Negative Predictive Value (NPV) is defined as probability that patients without two consecutive positive cHPVDNA do not develop OPSCC recurrence during the study period.
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UNC Lineberger Comprehensive Cancer Center
Lead sponsor
Mayo Clinic
Collaborator
National Institute of Dental and Craniofacial Research (NIDCR)
Collaborator
