NCT04564989 Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC
| NCT ID | NCT04564989 |
| Status | Recruiting |
| Phase | — |
| Sponsor | UNC Lineberger Comprehensive Cancer Center |
| Condition | Oropharyngeal Squamous Cell Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 220 participants |
| Start Date | 2020-11-19 |
| Primary Completion | 2033-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 220 participants in total. It began in 2020-11-19 with a primary completion date of 2033-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Wendell Yarbrough, MD
PRINCIPAL INVESTIGATOR
UNC Chapel Hill
Frequently Asked Questions
Who can join the NCT04564989 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Oropharyngeal Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04564989 currently recruiting?
Yes, NCT04564989 is actively recruiting participants. Contact the research team at lori_stravers@med.unc.edu for enrollment information.
Where is the NCT04564989 trial being conducted?
This trial is being conducted at Rochester, United States, Chapel Hill, United States, North Charleston, United States.
Who is sponsoring the NCT04564989 clinical trial?
NCT04564989 is sponsored by UNC Lineberger Comprehensive Cancer Center. The principal investigator is Wendell Yarbrough, MD at UNC Chapel Hill. The trial plans to enroll 220 participants.