NCT04564989Recruiting
Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC
LCCC 2044: Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC
Source: ClinicalTrials.gov · Last updated 28 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 220 (estimated)
- First submitted
- 14 Aug 2020
- Start date
- 19 Nov 2020
- Primary completion date
- 30 Nov 2033
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Diseases
- Head and neck cancer
- NCT number
- NCT04564989
What you commit to
- Study type: Observational
- Planned participants: 220
- From 19 Nov 2020 to the primary completion date, 30 Nov 2033
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of radiation therapy to the head and neck
- Prior history of head and neck cancer.
Other
- Inadequate pre-treatment tissue sample for tumor genomic analyses
Who the study is looking for
- ≥ 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| Trident Medical Center (HCA Healthcare ) Coordinator of this site? Confirm its status | North Charleston | United States | Recruiting |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.