Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC

Launched by UNC LINEBERGER COMPREHENSIVE CANCER CENTER · Sep 24, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a type of throat cancer known as HPV-associated oropharyngeal squamous cell carcinoma (OPSCC). The main goal is to see if doctors can predict whether this cancer will come back after treatment by looking at certain genetic changes and measuring HPV DNA in the blood. Researchers want to find out if changes in specific genes (TRAF3 and CYLD) and the presence of HPV DNA in the blood can help them make better predictions about a patient’s chances of recurrence. They will also explore if there's a connection between HPV DNA and the genetic changes.

To participate in this study, candidates should be adults aged 18 or older who have been diagnosed with biopsy-proven OPSCC but have not received any prior treatment. They should also have a specific type of tumor cell expression that indicates they have HPV. Participants can expect to provide blood samples and may undergo additional tests as part of the study. It’s important for potential participants to understand that they need to give informed consent and be able to follow the study’s treatment and follow-up plans.

Gender

ALL

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