Observing HPV DNA and genetic markers in oropharyngeal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to determine if the recurrence of HPV-associated oropharyngeal squamous cell carcinoma (OPSCC) can be predicted by analyzing mutations in specific genes (TRAF3 and CYLD) and measuring circulating HPV DNA in blood plasma. It will also explore the relationship between HPV integration and these mutations, assessing whether combining these factors enhances prediction accuracy for cancer recurrence. The study involves patients who are newly diagnosed and have not received prior treatment for their cancer.

Why it matters

Who can join: the full rules

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

Where it's running

• University of North Carolina at Chapel Hill
  Chapel Hill, North Carolina, United States Recruiting
• Trident Medical Center (HCA Healthcare )
  North Charleston, South Carolina, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Active not recruiting

Study contacts

• Principal investigator: Wendell Yarbrough, MD — UNC Chapel Hill
• Study coordinator: Lori Stravers
• Email: lori_stravers@med.unc.edu
• Phone: 919-966-4432

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.