LCCC 2044: Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC
UNC Lineberger Comprehensive Cancer Center
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 C…
Locations (3)
- Mayo ClinicRochester, Minnesota
- University of North Carolina at Chapel HillChapel Hill, North Carolina
- Trident Medical Center (HCA Healthcare )North Charleston, South Carolina