Official Title
LCCC 2044: Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC
Brief Title
Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC
Protocol ID
NCT04564989
Lead Sponsor
UNC Lineberger Comprehensive Cancer Center
Brief 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.
Study Period
Enrollment Count
220 participants
Eligibility Criteria
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
Filters
Oropharyngeal Squamous Cell Carcinoma
Carcinoma, Squamous Cell
Head and Neck Squamous Cell Carcinoma
Oropharynx Squamous Cell Carcinoma
RECRUITING
ADULT
OLDER_ADULT