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Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC

Recruitingn/aAges 18 Years - anyAllUNC Lineberger Comprehensive Cancer Center
NCT04564989 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

3 sites
Mayo Clinic
Rochester, United States
University of North Carolina at Chapel Hill
Chapel Hill, United States
Trident Medical Center (HCA Healthcare )
North Charleston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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