Observing HPV DNA and genetic markers in oropharyngeal cancer
LCCC 2044: Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC
UNC Lineberger Comprehensive Cancer Center · NCT04564989
This study is testing if checking for certain gene changes and HPV DNA in the blood can help predict if oropharyngeal cancer will come back in newly diagnosed patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UNC Lineberger Comprehensive Cancer Center (other) |
| Drugs / interventions | radiation |
| Locations | 3 sites (Rochester, Minnesota and 2 other locations) |
| Trial ID | NCT04564989 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with biopsy-proven oropharyngeal squamous cell carcinoma who are p16 positive and planned for definitive cancer treatment.
Not a fit: Patients with a history of prior head and neck cancer or radiation therapy to the head and neck will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved methods for predicting cancer recurrence in patients with HPV-associated OPSCC.
How similar studies have performed: Other studies have shown promise in using genetic and viral markers for predicting cancer outcomes, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, Minnesota and 2 other locations
- Mayo Clinic — Rochester, Minnesota, United States (ACTIVE_NOT_RECRUITING)
- 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)
Study contacts
- Principal investigator: Wendell Yarbrough, MD — UNC Chapel Hill
- Study coordinator: Lori Stravers
- Email: lori_stravers@med.unc.edu
- Phone: 919-966-4432
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Oropharyngeal Squamous Cell Carcinoma, Carcinoma, Squamous Cell, Head and Neck Squamous Cell Carcinoma, Oropharynx Squamous Cell Carcinoma, Human Papillomavirus, HPV, p16, Oropharynx