Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC
Recruiting
Observational Study
Oropharyngeal Squamous Cell Carcinoma
Carcinoma, Squamous Cell
Head and Neck Squamous Cell Carcinoma
Oropharynx Squamous Cell Carcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 220 (estimated)
- Sponsor
- UNC Lineberger Comprehensive Cancer Center · Other
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About This Trial
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 integratio…
Trial Locations
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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 le…
Contacts