Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC
Recruiting now
Conditions studied: Oropharyngeal Squamous Cell Carcinoma, Carcinoma, Squamous Cell, Head and Neck Squamous Cell Carcinoma, Oropharynx Squamous Cell Carcinoma
In brief
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.
Key facts
- Study ID
- NCT04564989
- Run by
- UNC Lineberger Comprehensive Cancer Center
- People needed
- 220
- Starts
- 2020-11-19
- Expected to finish
- 2033-11-01
- Last updated by the study team
- 2026-04-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥ 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
Where it is running
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
- Trident Medical Center (HCA Healthcare ) — North Charleston, South Carolina, United States (enrolling)
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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