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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
HPV+ OPSCC Patients Patients with p16+ squamous cell carcinoma of the oropharynx (or unknown primary) who will receive definitive cancer treatment.

Recruiting Locations

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
Contact:
Tuvara King
919-966-4432
tjking@med.unc.edu

Trident Medical Center (HCA Healthcare )
North Charleston, South Carolina 29406
Contact:
Vera Markovic
843-998-2819
Vera.Markovic@hcahealthcare.com

More Details

Status
Recruiting
Sponsor
UNC Lineberger Comprehensive Cancer Center

Study Contact

Lori Stravers
919-966-4432
lori_stravers@med.unc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.