NCT04564989Recruiting
Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC
UNC Lineberger Comprehensive Cancer Center
Start Date
11/19/2020
Completion Date
11/1/2033
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 Criteria
Age Range: 18 years to No maximum
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
Conditions
Oropharyngeal Squamous Cell CarcinomaCarcinoma, Squamous CellHead and Neck Squamous Cell CarcinomaOropharynx Squamous Cell Carcinoma
Locations
Mayo Clinic
Rochester, Minnesota 55905
United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
United States
Trident Medical Center (HCA Healthcare )
North Charleston, South Carolina 29406
United States