Carcinoma, Squamous Cell, Head and Neck Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma, Oropharynx Squamous Cell Carcinoma
Conditions
Keywords
Human Papillomavirus, HPV, p16, Oropharynx, OPSCC
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.
Interventions
None listed
Sponsors
UNC Lineberger Comprehensive Cancer Center
Mayo Clinic
National Institute of Dental and Craniofacial Research (NIDCR)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of OPSCC | From date of therapy completion until biopsy-proven recurrence, assessed up to 5 years | Patients will undergo post-treatment CT scans per institutional standard of care to detect cancer recurrence. Status of recurrence of OPSCC will be confirmed based on biopsy. |
| Progression-free survival | From beginning or end of treatment until date of CT-detected recurrence or date of death, assessed up to 5 years | Time-to-recurrence will be defined as time lapsed from end (or start) of treatment to first date recurrence (biopsy proven occur later) is detected by CT scans, or death. Otherwise, time-to-recurrence is censored at end of study date. |
| Positive Predictive Value | Baseline to up to 5 years | Positive Predictive Value (PPV) is defined as probability that patients with two consecutive positive cHPVDNA (i.e., detectable cHPVDNA) really develop OPSCC recurrence during the study period. |
| Negative Predictive Value | Baseline to up to 5 years | Negative Predictive Value (NPV) is defined as probability that patients without two consecutive positive cHPVDNA do not develop OPSCC recurrence during the study period. |
| Quality of Life questionnaire | Baseline until recurrence or up to 5 years | At specified timepoints before, during, and after treatment, patients will complete a questionnaire comprised of questions from the European Organization for Research and Treatment of Cancer (EORTC) QLQ H\&N35, which is for head and neck cancer patients, and EORTC QLQ C30, which is a general cancer assessment. |
Countries
United States
Contacts
CONTACTLori Stravers
CONTACTWendell Yarbrough, MD
PRINCIPAL_INVESTIGATORWendell Yarbrough, MD
UNC Chapel Hill
Outcome results
None listed