What this study is
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.
Study details
- Official title
- LCCC 2044: Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Conditions
- Oropharyngeal Squamous Cell Carcinoma · Carcinoma, Squamous Cell · Head and Neck Squamous Cell Carcinoma · Oropharynx Squamous Cell Carcinoma
- Enrolling
- 220 people
- Starts
- 2020-11-19
- Est. completion
- 2033-11
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (3)
2 openUniversity of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
- Tuvara King · Contact919-966-4432tjking@med.unc.edu
- Wendell Yarbrough, MD · Principal investigator
RecruitingTrident Medical Center (HCA Healthcare )
North Charleston, South Carolina, United States
- Vera Markovic · Contact843-998-2819Vera.Markovic@hcahealthcare.com
- David Neskey, MD · Contact843-998-2819david.neskey@sarahcannon.com
- David Neskey, MD · Principal investigator
RecruitingMayo Clinic
Rochester, Minnesota, United States
Active, not recruiting
Study team
Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID LCCC 2044
Principal investigator
Wendell Yarbrough, MD
UNC Chapel Hill
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.